The Senior Medical Advisor provides senior‑level medical and scientific leadership with a strong focus on pharmacovigilance and medical safety, while supporting broader medical affairs and evidence activities. The role is responsible for medical review and oversight of safety data across clinical and post‑marketing sources, ensuring accurate assessment of serious adverse events and maintaining oversight of assigned products’ safety profiles in compliance with global regulatory requirements, and IQVIA standards.

This position acts as a senior technical leader, partnering with cross‑functional and matrix teams, supporting clients locally and regionally, and representing medical safety findings in client and internal forums.

Key Responsibilities

• Perform medical review of clinical trial and post‑marketing AEs/SAEs/ADRs, including narratives, causality, seriousness, expectedness, coding, and queries.

• Provide medical oversight for safety surveillance activities for assigned products.

• Prepare, review, and contribute to aggregate safety reports (e.g., DSURs, PBRERs, RMPs, ad‑hoc regulatory reports).

• Author and medically review analyses of similar events (AOSE) and support signal detection activities.

• Review protocols, Investigator Brochures, and CRFs for safety content and data capture.

• Serve as a medical expert and internal consultant to pharmacovigilance, RWE, and project teams.

• Represent medical safety findings in project and client meetings; support audits and inspections.

• Act as Lead Safety Physician or senior backup on assigned projects, including escalation support when required.

• Mentor junior medical and safety team members and support training, transitions, and knowledge sharing.

• Ensure quality, compliance, and timely delivery of medical safety services.

• Maintain awareness of evolving pharmacovigilance and regulatory requirements.

Qualifications

• Medical Degree (MD) - Required

• 3+ years clinical practice experience post‑degree.

• 2+ years experience in pharmaceutical industry, CRO, or pharmacovigilance preferred.

• Strong knowledge of pharmacovigilance (ICSRs, aggregate reports), GCP, ICH guidelines, and safety databases.

• A dvanced English required.

• Strong scientific judgment, communication, and stakeholder management skills.