Job Description – Drug Safety / Medical Review Specialist
Role Summary:
Responsible for medical review and assessment of safety cases, ensuring accurate evaluation of adverse events and compliance with regulatory requirements.
Key Responsibilities:
- Perform medical review of clinical, spontaneous, and literature cases
- Assess causality, labeling, and case narratives
- Review seriousness, coding, and overall case quality (AE/SAE, medications, labs, history)
- Ensure compliance with SOPs and regulatory timelines
- Support safety teams with medical expertise and product knowledge
- Handle queries and follow-ups for Individual Case Safety Reports (ICSRs)
- Provide input on SUSAR cases
- Participate in audits, meetings, and safety forums
Required Skills:
- Strong medical and pharmacovigilance knowledge
- Understanding of regulatory processes
- Good communication and problem-solving skills
- Ability to prioritize and work in teams
- Computer proficiency (MS Office)
