Gxp & Research Applications In California
This is a new opportunity for a director, gxp & research applications full-time position in california.
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.
-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.
-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.+6 Other Responses
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.
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.
- 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.+49 Other Responses
Bio Research Quality & Compliance (brqc)
Bio research quality & compliance (brqc) - pharmaceutical r&d services
need expert with quantitative knowledge on supply market, market, pricing model, engagement model for quality assurance, quality analytics, quality management, quality management system oversight and quality planning & strategy of pharma r&d environment.
1. Supply capability analysis - supplier’s functional capability/ competency, client base information
2. Sourcing best practices - outsourced vs. In-house trend, cost drivers/components, costing/pricing models, resourcing/ engagement models, quality kpis for supplier selection
3. Market trends - macro level knowledge on how suppliers tackle local regulations and its impact on brqc, macro level trends on technology, innovation - modeling, predictive analytics and its impact on risk management, technologies that can support training, audits etc.Quality vs. Cost perspective - low cost sourcing.
Get in touch if you can help with all of above.+undefined Other Responses
Cleanroom Gloves At Pharma & Med Device Mfr.
We are looking to speak with safety managers, quality control managers, buyers, employee health & amp; safety managers. We want to have a better understanding of your use case, purchasing considerations and evaluation of quality standards for procurement of safety gloves in cleanrooms. We are particularly focused on pharmaceutical (sterile/injectable drugs) and med device manufacturers.
We like to engage multiple professionals for (up to) 1-hour paid phone consults. If interested, please respond with a few short statements to the questions below.
1. Were you part of the decision making process for cleanroom gloves in your company for the past 2 years?
2. Can you specify the type and features of the gloves that you are using in your company?
3. Can you please specify your clean room standard? (eg.
Iso classification 1, 2, 3,4, 5, etc or grade or class 1, 10, 100, 1000, 10,000, etc)
4. Can you speak about the implementation of sterile/non-sterile/both for your pharmaceutical environment? Can you briefly elaborate the process?+undefined Other Responses
We are seeking to hire for a pharmacovigilance (pv or phv) qppv position in the czech republic.
Senior level, 10+ years of drug safety, pharmacological science experience.
Collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
Here’s the basics for a qppv:
contact responsible for ensuring company (the product's marketing authorization holder or mah) meets its legal obligations for the monitoring of the safety of a medicinal product on the market. The qppv must reside in the eu, and should be permanently and continuously at the disposal of the mah.
Detailed information on the role and responsibilities of the qppv are specified in volume 9 of "the rules governing medicinal products in the european union." at a minimum the qppv should be appropriately qualified, with documented experience in all aspects of pharmacovigilance in order to fulfil the responsibilities and tasks of the post. If the qppv is not medically qualified, access to a medically qualified person should be available.+12 Other Responses
Looking for an expert in pharmacovigilance italy+4 Other Responses
New Jersey Pharmaceutical Compliance
Compliance specialist - bergen county nj
essential job function: responsible for interacting with customers on quality issues. Responsible for the receipt of all notices of investigations and logging them into the investigations spreadsheet. Responsible for the receipt of independent capas and logging them into the capa spreadsheet. Responsible for reviewing investigation reports for accuracy, compliance and completion. Responsible for performing internal and external audits and completing the pertinent audit agenda and reports.
• pharmaceutical background
• excellent documentation
• bachelor's degree, in science field desired
• 3-5 years investigation experience
• 5+ years in qa role in pharma industry
• at least 2 years of auditing experience
• 3-5 years working in a department responsible for assigning and assessing the effectiveness of capa’s
• solid oral dosage experience, would also consider a candidate with experience in liquids, semi-solid, capsules, injectables (if candidate possesses all other qualifications!)
general information: experience in the pharmaceutical industry. Bachelor’s degree in science field desired.
Job responsibilities include but not limited to:
• investigate deviations and initiate the appropriate corrective and/or preventive actions to prevent re-occurrence of the incident.
• perform root cause analysis.
• perform product impact assessment of deviations.
• provide qa support during the investigation process.
• perform tracking and trending of deviations and capas.
• prepare deviation and capa metrics on a monthly basis.
• provide support during fda inspections.
• responsible for the receipt all notices of investigations and logging them into the investigations spreadsheet.+4 Other Responses
I am looking for pv auditor located in egypt and lebanon for pv audit that will happen in q4 2016.+11 Other Responses
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!+27 Other Responses
Pharmaceutical Quality Assurance
Looking for a quality assurance supervisor - pharma+8 Other Responses
on behalf of ****, a global knowledge broker based in berlin, germany, i am searching for specialists, who could provide us with an expertise on the market of pharmacovigilance market. If you are interested in a consulting possibility, please, do not hesitate to contact me.
karolina ****+8 Other Responses
Local pharmacovigilance contact person in cis countries and russia+3 Other Responses