Job Description Summary

The Drug Safety Medical Director works within Drug Safety & Risk Management in Global Pharmacovigilance, providing medical leadership across proactive safety surveillance and lifecycle risk management activities. The role focuses on medical review of Individual Case Safety Reports (ICSRs), safety signal detection and evaluation, and benefit-risk assessment of the assigned products in alignment with global regulatory requirements.
The Medical Director partners closely with Pharmacovigilance Scientists and cross functional stakeholders to ensure timely, medically sound, and data driven safety decisions throughout clinical development and post marketing phases.

Job Description

Primary responsibilities

• Serves as Medical Reviewer for Individual Case Safety Reports (ICSRs), providing expert medical assessment and clinical judgment.
• Gathers, reviews, and evaluates scientific and clinical data to support the development, maintenance, and update of Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI).
• Prepares and contributes medical safety content for key regulatory documents, including but not limited to, Development Safety Update Reports (DSURs), PSURs/PBRERs, RMPs, and medical expert statements.
• Supports safety signal detection and evaluation activities in collaboration with PV Scientists, applying data‑driven decision‑making throughout the signal management process.
• Authors high‑quality safety review documents, signal evaluation reports, and provides recommendations on risk management actions in partnership with cross‑functional Safety Review Teams.
• Provides medical expertise and collaborates with PV Scientists in the preparation of scientifically robust and regulatory‑compliant responses to safety‑related questions from health authorities.
• Acts as a Subject Matter Expert (SME) for Global Pharmacovigilance and cross‑functional teams, providing guidance on applicable ICH, EU, US, and international clinical development and post‑marketing safety regulations, as well as product‑specific safety information.

• Participates in additional activities, special projects, or assignments as business needs evolve. Allocation of time across responsibilities may vary based on project scope and departmental priorities.

Required Qualifications

• Experience in drug safety risk management and pharmacovigilance (medical review of ICSRs, safety signal detection, medical review of aggregate reports and company core safety information). Relevant experience in clinical development or medical affairs in industry or with service provider will be considered.
• Minimum of 5 years of pharmaceutical/biotechnology PV experience. Global experience preferred.
• Strong knowledge in FDA, EU, ICH guidelines, initiatives and regulations governing pharmacovigilance.
• Proven ability to provide sound medical assessments of Individual Case Safety Reports (ICSRs).
• Proven ability to utilize MedDRA and assign appropriate MedDRA terms to describe adverse events and WHO DD dictionary coding to accurately capture and standardize information related to medicinal products.

Desired Characteristics

• Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.
   

  Note:

  
  To comply with US immigration and other legal requirements, it is necessary to specify the minimum number of years' experience required for any role based within the USA. For roles outside of the USA, to ensure compliance with applicable legislation, the JDs should focus on the substantive level of experience required for the role and a minimum number of years should NOT be used.

Additional Information