
Drug Safety Physician
2 weeks ago
Manage daily workload in conjunction with Manager for individual case processing, literature searches, aggregate reports generation and any other tasks relevant to the Pharmacovigilance Department.
- Medical review of ICSRs in APCER’s Pharmacovigilance database and aggregate reports for the purpose of expedited/periodic submission as per the Regulations and SOPs.
- Management of Compliance with the Company Standard Operating Procedures and regulatory requirements.
- Support in Signal detection of the ADRs with cases received from client's products (if applicable).
- Medical Review of PSUR as per the Regulations and SOPs (if applicable).
- Handling of medical query/spontaneous ADR cases as per applicable SOP (as applicable).
- Trains and mentors new medical reviewers in PVG (if required)
- Complies with applicable ISMS related procedures & policies
- Maintain awareness of changes to/new regulations affecting pharmacovigilance activities. Communicate new or changed regulations to management and to relevant members of the department in order to initiate any change in processes.
- Generation and Execution of company standard operating procedures (SOPs) and Work instructions (WI).
- Liaise effectively and maintain excellent relationship with the clients and internal/external contacts.
- To contact, as required the UK/US office(s) and customers/clients in order to achieve required outcomes and meet timelines.
- To carry out necessary administrative duties required for the job.
- Builds and maintains good relationships across functional units and company affiliates.
- Other duties as assigned by management.
Pay: ₹1,000,000.00 - ₹1,200,000.00 per year
Application Question(s):
- Are you a MBBS/MD?
**Education**:
- Bachelor's (required)
Work Location: In person
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