Work Schedule
Second Shift (Afternoons)

Environmental Conditions
Office

Job Description

Job Title: Pharmacovigilance Physician

Thermo Fisher Scientific Inc. is seeking a highly skilled and motivated Pharmacovigilance Physician to join our world-class team. As a Pharmacovigilance Physician in M-SERM department, you will provide medical oversight of pharmacovigilance activities including but not limited to medical review and analyses for clinical trial and post authorized products.

Job Requirements:

• Graduate or Postgraduate Medical Degree (MD, MBBS)
• 0-2 years of experience in pharmacovigilance or related fields
• Strong understanding of regulatory requirements and good clinical practices.
• Outstanding analytical and problem-solving skills.
• Ability to successfully implement and manage multiple projects, strictly adhering to deadlines.
• Excellent communication skills, both written and verbal.
• Collaborative approach with a dedication to inclusivity and teamwork.

• Provide medical oversight of pharmacovigilance activities to ensure compliance with company SOPs, client directives, and regulatory requirements.
• Attend and present at sponsor meetings, offering expert medical and pharmacovigilance consultation to clients and project team members.
• Support business development activities through medical expertise.
• Conduct medical reviews and analyses for clinical trial serious adverse events, focusing on triage, seriousness, expectedness, causality assessment, and appropriate adverse event term selection using MedDRA terminology.
• Review and prepare periodic safety reports (e.g., PBRER, PSUR, DSUR) and other client deliverables (e.g., labeling reconciliation documents, CTD modules, REMS, RMP, and CSR).

• Identify and investigate safety signals, contributing to the management of the benefit-risk profile of assigned products.