Drug Safety Physician (MBBS/MD) Full-time Job

Job Description –

• Manage daily workload in conjunction with Manager for individual case processing, literature searches and any other tasks relevant to the Pharmacovigilance Department.

• Medical review of ICSRs in APCER’s Pharmacovigilance database 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.

• 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).