Drug Safety Physician

2 weeks ago


Noida Uttar Pradesh, India Apcer Life Sciences Full time

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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