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Clinical Safety Risk Management (CSRM) Director

Employer
Merck & Co.
Location
Rahway, NJ; North Wales, Pennsylvania
Start date
Nov 9, 2022

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Clinical Safety and Risk Management (CSRM)

Director / Principal Scientist

Description:

Under the general direction of an Executive Director, Oncology, the CSRM Principal Scientist is a leader in drug safety and is responsible for overall clinical risk management and safety surveillance of assigned investigational and marketed drugs.

Key responsibilities include but are not limited to the following:

  • Support product development activities via Risk Management and Safety Teams and Product Development Teams and other related sub-team participation, including participation in internal and joint internal/external research project teams relevant to the development of new compounds and the further study of marketed compounds.

  • The CSRM Principal Scientist may work closely with a cross-functional group of experts in epidemiology, regulatory affairs, statistics, and manufacturing to manage safety topics under evaluation.

  • Duties include all aspects of safety data evaluation, including assessing safety from multiple sources, e.g. clinical trials, literature and post-approval use and ensuring completeness of safety information in worldwide package circulars.

  • Responsible for safety surveillance activities such as safety signaling reviews, using medical judgment in review of individual cases as well as overseeing the medical judgment of other staff.

  • Risk management activities such as contributing to recommendations for pharmacovigilance actions and making recommendations for labeling.

  • Ensuring that the safety sections of Company product circulars are medically and scientifically appropriate.

  • Analyzing and summarizing the findings from available safety data to support decisions.

  • The CSRM Principal Scientist may supervise the activities of CSRM Staff in the execution of safety data analysis and medical writing.

  • Responsible for the development of worldwide post-market risk management plans, pharmacovigilance strategies and risk minimizations activities as warranted.

 

Qualifications:

Minimum required education:

Required: MD, DO, or equivalent.

Required Experience and Skills:

  • Minimum of 3 years clinical experience.

  • Excellent written and verbal communication skills as well as analytical skills.

Preferred Experience and Skills:

  • Drug safety, pharmacovigilance and/or risk management industry experience in both the investigational and post-approval environments.

  • Board certification highly desirable.

  • Oncology experience.

 

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