Pharmacovigilance Medical Leader - Clinical Safety

Merck; Lansing (MI); À distance; USD 282 000 - 444 000; Plein temps

Résumé du poste

Merck, Rahway, NJ, seeks a CSRM Physician to lead pharmacovigilance and clinical risk management for investigational and marketed products. You chair safety teams, guide risk management plans, and drive safety data evaluation from multiple sources, including trials, literature, and post-approval use.

You will work with cross-functional teams across development, regulatory, and manufacturing to ensure safety strategies meet global requirements.

Qualifications

• MD/DO or equivalent required.
• Board Certification preferred.

Responsabilités

• Lead pharmacovigilance activities and safety surveillance for assigned products.
• Develop and maintain Risk Management Plans and pharmacovigilance strategies.
• Prepare safety summaries and regulatory documents (CTD components, PSURs, etc.).
• Collaborate with cross-functional teams to ensure global pharmacovigilance alignment.
• Oversee labeling review related to safety and risk management.

Connaissances

Clinical Risk Management

Clinical Safety

Pharmacovigilance

Regulatory Documents

Risk Management

Safety Assessment Reports

Formation

MD/DO or equivalent

Board Certification

Description du poste

Merck, Rahway, NJ, seeks a CSRM Physician to lead pharmacovigilance and clinical risk management for investigational and marketed products. You chair safety teams, guide risk management plans, and drive safety data evaluation from multiple sources, including trials, literature, and post-approval use.

You will work with cross-functional teams across development, regulatory, and manufacturing to ensure safety strategies meet global requirements.