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Sr. Medical Director, Surveillance and Risk Management

Cambridge, Massachusetts 02142

Post Date: 03/05/2018 Job ID: 1765 Job Category: Clinical: Pharmacovigilance (PV)/Drug Safety

Our client is seeking a Sr. Medical Director, SRM and they will serve as the global lead for surveillance and risk management of all products marketed and in development.   This key position will lead a team of medical doctors and PV scientists, and interact across functions and at various management levels. The head of SRM and his/her team are responsible for the detection and investigation of safety signals, assessment of the need for risk mitigation activities, and the continuous benefit risk evaluation of all products. This role will interact with senior management and closely collaborate with colleagues from other functions such as Clinical Research, Regulatory Affairs, Data Science, Medical Affairs, Clinical Operations.

Job Responsibilities:

Key responsibility is to build and lead a high performing team of medical safety experts to:
  • Medically assess ICSRs from development and post-approval sources
  • Have an in depth understanding of product’ s safety profile as well as the patient profile in approved or studied indications
  • Monitor patient safety in clinical trials, in close collaboration with Clinical Research and Data Sciences
  • Lead Safety Management Teams
  • Evaluate safety data from various sources, including literature, clinical trials, internal and external safety databases. Propose proactive PV Strategies.
  • Apply, or introduce best industry practices to safety surveillance, including signal detection and assessment as well as benefit-risk evaluations.
  • Apply sound judgment in matters of recommended actions including label updates, risk mitigating activities and communications to health authorities, prescribers or consumers.
  • Produce excellent aggregate benefit-risk reports, and scientifically sound discussions and summaries, in support of decision making
  • Develop and propose post-market risk management plans, risk mitigation strategies as needed and monitor effectiveness

At the individual level, the head of SRM will:
  • Play a key role in the Company Safety Oversight Committee.
  • Interact with health authorities related to safety matters
  • Present to investigators, or other medical or professional audiences
  • Approve regulatory and clinical documents for submission.
  • Present or represent the DS PV position where needed
  • Report to the VP Drug Safety and Pharmacovigilance

Qualifications/ Requirements:
  • MD, DO, or equivalent
  • Minimum of (2) years Clinical experience after medical education
  • Minimum of (10) years industry experience in Pharmacovigilance and Risk Management
  • Track record of successfully leading teams.
  • Track record of successful safety issue management
  • Training or experience in quantitative research, epidemiology, public health
  • Extensive experience in both investigational and post-approval context
  • Board certification is a plus

Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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