APCER is Hiring Drug Safety Physician
Role & Responsibilities:
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 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).
- 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.
- Must have good presentation skills and the ability to give presentations.
- Strong interpersonal & communication skills
- Ability to work independently
- Knowledge of regulatory requirements
Education Qualification & Experience
Education: MBBS / MD
Experience: 1 to 5 Year in Pharmacovigilance