Research Consultant at Grassik Search
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Associate Vice President - Drug Safety (15-20 yrs)
- Medical Review of ICSR's in Pharmacovigilance database and aggregate reports for the purpose of expedited/periodic submission as per the Regulations and SOPs.
- 15+ yrs of exp
- Leadership role,Team Handling
- Signal detection of the ADRs with cases received from client's products
- Medical Review of aggregate reports per the Regulations and SOPs
- Handling of medical query/spontaneous ADR cases as per applicable SOP
- Generation and review of SOPs and WIs and execution of company SOPs
- Monitoring the work progress, ensure timely delivery, participating in status meetings, updating project progress to the stakeholders
- Maintain awareness of changes to/new regulations affecting PVG activities.
- Execution of company Standard Operating Procedures
- Trains and mentors new employees in PVG (if required)
- Builds and maintains good relationships across functional units and company affiliates
- Complies with applicable ISMS related procedures & policies
- To carry out necessary administrative duties required for the job.
- Other duties as assigned by management
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