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10 days old

Medical Director Pharmacovigilance (Postmarketing Team)

Kelly Services
Cambridge, MA 02238
Kelly is hiring a **Medical Director Pharmacovigilance (Postmarketing Team)** for one of our biotech clients


+ 1 year contract to start

+ Remote during duration of contract but can only be converted if contractor can relocate/be onsite 2-3 days per week

+ Pay: Negotiable


**The most important experience are:**

Postmarketing safety experience

Author health authority responses especially to European Medicines Agency and FDA

Signal detection and evaluation, risk management

Safety Label updates

Author aggregate safety reports and risk management plans (EU)


**OBJECTIVES:**

Responsible for the oversight of signal detection and risk management activities for designated global/regional product(s)

Support Therapeutic Lead

Flexible to support compounds/initiatives outside of primary therapeutic area(s) as directed by business and departmental needs


**ACCOUNTABILITIES:**

Expectation of GSL role for marketed compound(s) in close association with the TAL.

Company wide safety expert for his/her compound responsibilities

Intimate knowledge of safety, including any emerging safety concerns and risk/benefit profile for own compounds with input for other compounds as needed.

Serving in a leadership capacity for strategically important programs

Responsible for development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes but is not limited to: direct interaction with Regulatory authorities, authorship of safety summaries to support changes to the PI/SmPC, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs etc

Training and mentoring of Pharmacovigilance Scientists

Perform activities required to serve as Global PV physician:

- Review and oversight of safety data, both non-clinical and clinical

- Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities

- Interactions with external experts and regulatory agencies and partner/co-development companies

- Authorship and sign off of Safety Monitoring Plan/Risk Management Plan

- Lead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators

- Direct the set up of safety procedures and development of safety exchange agreements for co-development projects

Maintain professional knowledge and accreditation by active participation in continuing medical education activities


**EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:**

Qualified physician (License, e.g. GMC registered, preferred)

Knowledge of principles of epidemiology and statistics.

Critical thinking and analytical skills and ability to make high level decisions

Excellent oral and written communication skills including ability to present to large internal/external groups

Good level of computer literacy with Microsoft applications

Minimum of 8 years experience in pharmacovigilance, clinical research or clinical development

2-3 years clinical experience with patients following post-graduate training with significant knowledge of general medicine.

Must have worked in Global Pharma Setting.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-09-13 Expires: 2021-10-14

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Medical Director Pharmacovigilance (Postmarketing Team)

Kelly Services
Cambridge, MA 02238

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