Drug Safety Physician (MBBS/MD)

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).