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  1. 1. Provide a clear description of your needs and your expectations of an expert, consultant or job candidate and Zintro will match it with the most relevant professionals in our platform.
  2. 2. Within a day or two typically 6 - 12 Experts, who have opted-in, will contact you with a brief explanation of their qualifications and how they can help.
  3. 3. You can communicate back and forth, qualify each other, connect and pay fees to Experts through Zintro.
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Recent Drug Safety Inquiries

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Gxp & Research Applications In California

This is a new opportunity for a director, gxp & research applications full-time position in california. Overview: reporting to the vp of information technology, this position will be responsible for defining and maintaining global gxp and r&d application services. The successful candidate will have extensive experience with pharmaceutical and biotech it systems, vendor management, cross-functional team management, cfr part 11 and gamp 5 regulations, systems validation, and change control. This position will provide leadership to the application services team and the company. It will consult with the business to achieve successful gxp and r&d system development and completion of the it department’s objectives, projects and priorities. He or she will provide work direction, development coaching and performance feedback to application services staff while establishing and maintaining positive relationships with relevant business partners. Responsibilities: -provide production and development support for existing and future multi-tier gxp and research applications. -execute agreed upon service levels (i.E. Project schedules, system availability, & service quality). -review systems requirements and prepare recommendations anticipating future application needs. -direct the analysis, design, development and installation of it supported applications in accordance with established sops. -direct the it process development team to establish and maintain it sops, wis and related documents. -partner with qa to manage systems validation, periodic reviews and vendor assessments. -prepare operational forecasts and requirements, including monthly reports and budget analyses. -provide regular performance feedback to employees including written performance reviews. Lead individual projects as assigned using software development life cycle (sdlc) methodologies. Qualifications: -bs degree in computer science, business or equivalent experience. -ten to fifteen years of experience supporting gxp it systems with 3 to 5 years’ experience in the following: -it biotech project management experience in a multinational environment; -it management experience in a biotech/pharmaceutical environment managing systems supporting drug safety, pharmacovigilance, regulatory compliance, quality management and compliance, medical information or clinical trials software; and, -it working knowledge in a biotech research and lab environment, familiar with lab systems implementation and system requirements. -working knowledge of cfr part 11 requirements and direct experience with systems implementation in a validated environment. -must possess an understanding of business processes related to pharmaceutical corporate activities. Contact us here on zintro for more details.

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    Marie |Regulatory compliance/Quality System/ASQ

    Hello: I have 14 years experience working in the industry. I have been a certified auditor since 2...

    10.5 Hours Later
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    Frank |Zintro Expert

    Dear Sir/Madam, I have the required experience and ***** excel at this position. Experience...

    10.7 Hours Later
+6 Other Responses
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Pharmacovigilance

Pharmacovigilance drug safety

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    Krishna |Principal

    Can you provide any other details?...

    14 Minutes Later
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    Jose Alberto |Pharmacovigilance consultant

    Do you consider someone working from the EU?...

    46 Minutes Later
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    Raj |Associate Director

    Hi , thanks for the inquiry. Please let me know the ***** India and what kind of help is neede...

    55 Minutes Later
+33 Other Responses
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Pharmacovigilance Auditing

I am looking for pv auditor located in egypt and lebanon for pv audit that will happen in q4 2016.

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    Steve |CEO

    I have conducted over 100 PV audits and would be happy to help you with this....

    3.6 Hours Later
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    Jose Alberto |Pharmacovigilance consultant

    We are not ***** Egypt and Lebanon, but can do PV audits. PVpharm. Please contact us with more ...

    3.7 Hours Later
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    Christopher |Principal Consultant

    We can assist you with your PV audits....

    3.8 Hours Later
+11 Other Responses
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Rx To Otc Switch Evaluations

Rx to otc switch trials: i am gowthami, research analyst working for ************, a procurement research company currently i am doing a research on rx to otc switch trials. I request you to provide some insights on rx to otc switch a€“ actual use trial market ( market size and regionwise split) and supplier market(pricing models for these trials, how these trials are conducted in different regions, drivers and constraints for these trials in different regions, who are the suppliers/cro for these trials in different regions). This will be of immense help for my research and a great value add to my research report. I request you to guide me through this research by providing your valuable insights.

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    Courtland |CEO

    If you are seeking comments from US, please contact us. ...

    1.9 Days Later
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    Maily |National Pharmaceutical Coordinator

    Good morning, I live in Colombia-South America, so I want to know if you are interested in this mark...

    3.9 Days Later
+2 Other Responses
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Pharmacovigilance Business Development

Job title: business development manager job location: open (us and uk) job type: full-time please note: this position is only open to u.S. And u.K residents seeking full-time employment. No consultants please. Position summary: will work collaboratively with other colleagues to increase sales within the life sciences industry. Responsibilities will include full cycle sales including; researching, identifying, cold/warm calling, getting client meetings, listening and understanding client needs, addressing client concerns/objections, proposing solutions, negotiating, obtaining sows and closing the deal. Are expected to quickly develop credibility with customers/prospects and build trust through professionalism and knowledge of our services and products. **essential duties and responsibilities**: - prospect accounts focusing on safety related to our products and services - identify and develop new accounts and following up on existing leads - develop and maintain positive and productive relationships with key target accounts - manage assigned accounts to generate both incremental and repeatable annual business - initiate and manage rfi and rfp process and negotiate terms for all account programs and projects - work collaboratively with the services organization to ensure a complete and professional delivery of our software and service solutions - collaborate with our executives and smes to maximize account coverage - maintain knowledgeable understanding of changing regulatory guidelines and mandates affecting the industry community **job experience and qualifications**: - must demonstrate a sustained (7+ years) and successful track record selling professional services to pharmaceutical, biotech, medical device, and/or clinical research organizations. - selling drug safety consulting services and products is desired. - candidates should exhibit an understanding of the regulatory pharmacovigilance process for both pre-marketed and post-marketed stages of a product. - experience working with regulatory affairs departments, product safety related departments, or regulatory submissions is highly desired. - experience with data-mining or statistical signal detection products is desirable. - demonstrated track record of success working with senior level management in a fast paced growth environment is essential. - full sales cycle experience is required (prospect, identify opportunities, propose solutions, negotiate, close). - strong, quality-oriented proposal writing and proposal management experience. - ambitious, driven and self-motivated personality is required. - college degree or equivalent experience required. - willing to travel throughout the us, estimated up to 80%. - background in software as a service (saas) market is preferred. **we offer**: - competitive base salary + commission. - benefits: 100% medical/dental for employee and his/her family. Interested applicants should reply with a brief summary of their relevant experience and attach their latest cv on zintro. Please note: this position is only open to u.S. And u.K residents seeking full-time employment. No consultants please.

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    Terry |Regional Sales Manager

    Please accept my resume for the Business Development Manager position. Thank you, Terry Brown...

    2.5 Hours Later
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    Alan |Consultant

    Thanks for reaching out. But altho' I have drug safety and reg submission experience , I have not w...

    4.2 Days Later
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    Ajay |

    yes, I can do this job....

    6 Days Later
+49 Other Responses
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Local Pharmacovigilance -italy

Looking for a pharmacovigilance local qppv in italy

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    Graeme |Director of Pharmacovigilance. PharSafer

    Dear Sirs, We can help in this respect having local QPs and knowledge of the EU safety reporting, so...

    5 Minutes Later
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    Vijay Venkatraman |Managing Director & CEO, Oviya MedSafe

    Hello! We can support this requirement as we have EU QPPVs and Italy Local QPPVs on our panel. Pleas...

    33 Minutes Later
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    AMT |Drs., MSC DVM

    Hello i am interested and experienced both human and veterinary. Please forward my details for a tel...

    4.2 Hours Later
+4 Other Responses
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Chief Medical Officer

We're looking for a chief medical officer: this position serves as a clinical and medical leader of the company and is responsible for developing and implementing the overall medical and clinical strategy that advocates for our patients overall health and well-being while delivering innovative products and technologies.  the desired candidate will be skilled in clinical program design and execution in the context of a development organization. Experience and knowledge in interactions with clinical investigators, collaboration with regulatory affairs, and fda interactions is required. Essential duties and responsibilities include the following. Other duties may be  accountable for the entire clinical development process  conceive and execute clinical strategy for all technology platforms  build, develop, and lead a motivated and engaged matrix team who are responsible for the day-to-day design and execution of clinical programs  lead preparation of clinical sections of all relevant regulatory filings (ide, pma, ind, clinical study reports, nda/bla, etc)  design and oversee protocols for all phases of a clinical program  advise on first in human decision point and endorse first dosing in humans  serve as an expert on clinical and medical issues  review study data, including safety monitoring, sae reporting, and analysis/tracking of emerging efficacy profile  write final study reports and prepare of documents for regulatory submission  interact with the broader invivo organization to share expertise  interact with key opinion leaders to ensure implementation of latest clinical thinking and guidelines into clinical development plans, as well as consideration of novel clinical methods  serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors  manage strategic relationships with key partners  assist in the development of publications, abstracts, and presentations  represent the company at scientific meetings and presentations, interact with foundations, as well as other public relations opportunities  support business development activities as needed, including due diligence human resources:job descriptions:chief medical officer job description.Docx 7/16/2015  serve on leadership team of and provide clinical development insight to investment decisions  md or equivalent medical qualification  deep understanding of the biotechnology environment and the drug/device development process  demonstrated knowledge of designing, executing and delivering clinical programs to produce both timely and good quality data including knowledge of innovative clinical trial principles and methodologies  strong focus on finding innovative ways to leverage external expertise and funding, taking risk, focusing on new methods, exploring adjacent scientific  strong interpersonal skills and expert team player with demonstrated ability to build consensus and drive change across all levels of the organization, including senior management.

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    Jeffrey |President and Managing Director

    I have been working full-time for the past 16 years as a consultant. I "live" at the intersection o...

    27 Minutes Later
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    Michael |CMSO , Chief Medical Strategies Officer

    Working as a healthcare professional for over 25 years, I have optimized the growth and profitabilit...

    40 Minutes Later
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    Roman |CMO

    I have worked in drug development for more than 15 years in variety of therapeutic areas and roles, ...

    46 Minutes Later
+11 Other Responses
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Pharmacovigilance

Pharmacovigilance department structure in top global pharma companies. Organization structure staff strength job roles and responsibilities

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    Irina |Therapeutist, medical director

    i am pharmacologist and clinical pharmacologist...

    10 Minutes Later
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    Samia |manager

    Hello, I have already developed pharmacovigilance department, please contact me for more details. M...

    24 Minutes Later
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    Raquel |R+D Quality Assurance Auditor

    Dear User, Is it possible to have your e-mail? Your questions require a wide response and I'm not su...

    34 Minutes Later
+14 Other Responses
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Pharmacovigilance

Looking for global qppv psur and pv/drug safety consultant for an ongoing project in basel, switzerland. This is a backfill for someone who is leaving in december so immediate availability is necessary. Message me for more details? Thx!

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    Vivek |Associate Professor in Pharmacology & Cl

    Would you be interested in a perfect academic and experienced background? If yes, pleaee contact me....

    30 Minutes Later
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    Vijay Venkatraman |Managing Director & CEO, Oviya MedSafe

    If you are interested in outsourcing/contracting this activity to my organization, we would be happy...

    40 Minutes Later
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    Richard |Medical Director

    SUMMARY OF ***** An MD/PhD with over 10 years experience of clinical research and drug saf...

    45 Minutes Later
+27 Other Responses
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France Pharmacovigilance

Dear, i would like to ask you, if you are interested to be a local pv person in france. We wish to submit a dcp in march 2015 for ibuprofen and paracetamol combination tablet . In accordance to article 104(4) of directive 2001/83/ec we require a contact person for pharmacovigilance issues at a national level for. This local pharmacovigilance contact will report to the qualified person responsible for pharmacovigilance activities. Can you please provide me with the price estimation for the above-mentioned activities? Thank you in advance. Best regards, maciej

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    Michael |Principal Consultant

    Dear Maciej Our company can offer the services of the local pharmacovigilance person in France under...

    4.3 Hours Later
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    Vijay Venkatraman |Managing Director & CEO, Oviya MedSafe

    Dear Maciej, Our ***** Local QPPVs (LRPs) in France and we can offer cost-effective serv...

    4.4 Hours Later
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    AMT |Drs., MSC DVM

    Dear friend, I would like to participate. I have to find out if I do comply with the *****ir...

    4.4 Hours Later
+10 Other Responses
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Argus Implementation

Job title: argus implementation engineer job location: parsippany, nj job type: full-time please note: this position is only open to u.S. Residents/citizens seeking full-time employment. No consultants please. **position summary**: - argus implementation engineer will work collaboratively with other colleagues to satisfy current client’s needs through our managed services offerings. - willing to travel to clients on an “as needed” basis - 5-7 years of experience - must know argus drug safety suite. Willing to look at folks that have worked with arisg as well **essential duties and responsibilities**: -  strong with integration and configuration related to argus safety suite: - argus interchange, argus safety, argus insight (3-5 years exp.) -  axway interchange (3 to 5 years exp.) -  ability to write technical documents (design/technical  specifications, installation/operational qualifications) **salary**: depends on experience (doe) **benefits**: 100% medical/dental for employee and his/her family interested applicants should reply with a brief summary of their relevant experience and attach their latest cv on zintro. Please note: this position is only open to u.S. Residents/citizens seeking full-time employment. No consultants please.

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    James |General Manager

    Resume attached. Please contact me at 636 629 2613​​​...

    19.5 Days Later
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    Himanshu |

    I am *****ultant with 3 years of experience in PV domain working on Argus Safety, Axway Syn...

    20.9 Days Later
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    Arthur |Zintro Expert

    Sounds interesting. I'd like to learn more. Feel free to give me a call. My phone number is shown b...

    27.4 Days Later
+7 Other Responses
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Regulatory Affairs

We are a pharmacovigilance and medical service cro operating globally. We do not perform regulatory work and rely on outside consultants to work with clients. We are seeking reciprocal arrangments where for drug safety and medical services work this is provided to us and all regulatory work goes forward to our agents. We currently work with approx. 250+ pharma companies. Anyone interested should contact me.

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    Barton |President

    Hi Graeme, Not sure what you are aiming at here but I would be delighted to work on drug safety ass...

    8 Minutes Later
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    Balvant P |PRESIDENT

    Yes, I am interested. Please send me details on this project. With best regards. Sincerely, ...

    12 Minutes Later
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    Leona |President and Principal Consultant

    Hello I am interested in partnering with your organization. My name is Leona Saunders, I work as a...

    6 Hours Later
+47 Other Responses
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