
Senior Medical Safety Physician
5 days ago
- Medical Review aggregate reports (PSUR, PBRER, ADCO & DSUR) and screening of scientific literature for periodic submission as per the Regulations and SOPs.
- Manage daily workload in conjugation with line manager for aggregate reports generation and any other tasks relevant to the Pharmacovigilance Department.
- Generation and review of SOPs and WIs and execution of company SOPs.
- Compliance to project guidelines
• Execution of Company Standard Operating Procedures - Maintain awareness of changes to/new regulations affecting PVG activities.
- Trains and mentors new medical reviewers in PVG (if required).
- To carry out necessary administrative duties required for the job.
- Other duties as assigned by management.
- Builds and maintains good relationships across functional units and company affiliates.
Preferred candidate profile
Proficiency in Aggregate Report.
Well versed with technical writing requirements for US and EU.
Good therapeutic knowledge.
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