We are looking for Sr. Drug Safety Physicians to do the Medical Review of ICSRs and Aggregate Reports, can do the signal detection & handle medical query/spontaneous ADR cases for a leading MNC CRO
- Manage daily workload in conjugation with Senior Manager for individual case processing, literature searches, aggregate reports generation and any other tasks relevant to the Pharmacovigilance Department.
- Medical Review of ICSR’s in pharmacovigilance database and aggregate reports for the purpose of expedited/periodic submission as per the Regulations and SOPs.
- Signal detection of the ADRs with cases received from client’s products
- Medical Review of aggregate reports per the Regulations and SOPs
- Handling of medical query/spontaneous ADR cases as per applicable SOP
- Generation and review of SOPs and WIs and execution of company SOPs
- Monitoring the work progress, ensure timely delivery, participating in status meetings, updating project progress to the stakeholders
- Maintain awareness of changes to/new regulations affecting PVG activities.
- Execution of company Standard Operating Procedures
- Trains and mentors new employees in PVG (if required)
- Builds and maintains good relationships across functional units and company affiliates
- Complies with applicable ISMS related procedures & policies
- To carry out necessary administrative duties required for the job.
- Other duties as assigned by management
- M.B.B.S / M.D
- Relevant experience (3-5 years) in Pharmacovigilance
- Excellent written & spoken English
- Good time management and presentation skills
- Experience in team management
We know the industry just as well as you, and are we committed to providing you with the best placement experience possible.