Kelly Services REMOTE Medical Director - Pharmacovigilance in Cambridge, Massachusetts
Kelly Services is currently seeking a Medical Director - Pharmacovigilance in Cambridge, MA to work an initial 6-month contract assignment for one of our top clients. Kelly is a full-service workforce solutions provider to 98% of the Fortune 100™ companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.
This role has the potential to convert to a permanent role.
The Medical Director will support developmental programs, including both early and late stage development, and is responsible for the oversight of signal detection and risk management activities for designated global/regional product(s), together with global safety lead.
Primary Responsibilities of the Medical Director - Pharmacovigilance:
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 complex and 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, significant contribution to MAAs and NDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs etc.
Training and mentoring of Pharmacovigilance Physicians and Specialists
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
Review of safety data and participate in dose escalation decisions
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 and Experience Requirements of the Medical Director - Pharmacovigilance :
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
For immediate consideration, please send your resume in a WORD document to email@example.com
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 interests—it’s 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, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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. 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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