Drug Safety Physician (MD)

Why This Role Matters
• Contributes to global patient safety and benefit-risk balance
• Strengthens strategic medical oversight within Global Pharmacovigilance
• Ensures regulatory compliance with international safety standards
• Enhances global safety governance and decision-making processes

Job Description
• Provide medical safety oversight at a global level
• Conduct medical review of ICSRs and aggregate safety data
• Lead signal detection and benefit-risk evaluation activities
• Contribute to PSUR, DSUR, PBRER, and RMP documentation
• Support regulatory submissions and health authority interactions
• Collaborate cross-functionally with clinical, regulatory, and medical affairs teams

Key Features of the Role
• Strategic medical safety position
• High visibility within global safety structure
• Direct interaction with regulatory authorities
• Involvement in global governance and decision-making
• Non-operational pharmacovigilance role

Responsibilities
• Perform in-depth medical review of individual case safety reports
• Evaluate emerging safety signals and recommend risk mitigation strategies
• Ensure compliance with GVP and ICH guidelines
• Support regulatory inspections and audits
• Contribute to global safety strategy discussions

Required Qualifications
• MD (Doctor of Medicine) – Mandatory
• Minimum 3+ years experience in Drug Safety / Pharmacovigilance
• Strong knowledge of GVP and ICH guidelines
• Experience working within a global pharmaceutical environment

Educational Requirements
• Medical Doctor (MD) degree (mandatory)
• Additional certification in pharmacovigilance or drug safety (preferred)

Experience and Skills
• Expertise in signal detection and benefit-risk assessment
• Experience with EMA and FDA interactions
• Strong analytical and clinical judgment skills
• Ability to work in cross-functional global teams
• Excellent written and verbal communication skills

Age Eligibility
• As per company policy
• No specific age criteria mentioned

Salary Insights
• Competitive salary aligned with Basel life sciences market
• Additional corporate benefits as per global pharma standards
• Compensation based on experience and expertise

Company Overview
• Global pharmaceutical organization
• Strong presence in international markets
• Focused on innovation, safety, and regulatory excellence
• Operates within one of Europe’s leading life sciences hubs

FAQs

Q1. Is this an operational pharmacovigilance role?
No, this is a strategic medical safety position focused on oversight, governance, and benefit-risk evaluation rather than operational case processing.

Q2. Is MD mandatory for this role?
Yes, an MD qualification is mandatory.

Q3. What regulatory bodies will the candidate interact with?
The role involves interaction with agencies such as the European Medicines Agency and the U.S. Food and Drug Administration.

Q4. How much experience is required?
A minimum of 3+ years in Drug Safety or Pharmacovigilance within a global pharmaceutical environment is required.

Q5. Is global pharma experience necessary?
Yes, experience within a global pharmaceutical company is required due to the strategic and international scope of the role.

Application Tips
• Highlight MD qualification clearly in your CV
• Emphasize experience in signal detection and benefit-risk evaluation
• Mention regulatory interaction experience (EMA/FDA)
• Demonstrate strong knowledge of GVP and ICH guidelines
• Showcase strategic contributions beyond operational PV activities