Pharmacovigilance Scientist

**Description**
- Responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.
- Support Medical Safety Assessment Physicians (MSAP) in leading Safety Data Review (SDR) Teams.
- Appropriately perform core signal detection activities and elevate program or portfolio issues impacting key MST programs, priorities, resources, and milestones with appropriate oversight.
- Author responses for safety data queries and contribute to specified PV sections of the Periodic Benefit Risk Evaluation Report (PBRER) and Development Safety Update Report (DSUR).
- Ensure pharmacovigilance regulatory compliance with oversight
- Lead Safety Data Review (SDR) Teams and participate in related PV and product-development subteam(s).
- Appropriately elevate signal detection findings impacting key MST activities, milestones, and documents to the MST Chair.
- Support individuals in aspects of project management, drug development and MST requirements, as appropriate to meet overall MST/subteam needs.
- Author and contribute to specified PV sections of the PBRERs and DSURs with oversight
- Author responses to safety data queries from health authorities including coordination and integration of scientific, medical, and regulatory input from a variety of scientific sources and functional groups, to support responses to safety data/ad hoc queries and HA requests.
- Perform periodic review and summary of pertinent safety related literature and analysis of pre-determined core signal data.
- Collaborate within and across company functions with appropriate disciplines to identify and ensure management of internal and external documentation and support when required.
- Share with individuals and teams on these applied learning's.

**Salary**: ₹16,500.00 - ₹72,000.00 per month

**Benefits**:

- Internet reimbursement

Schedule:

- Day shift

Supplemental pay types:

- Performance bonus

Ability to commute/relocate:

- Wagholi, Pune, Maharashtra: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Higher Secondary(12th Pass) (preferred)

**Experience**:

- total work: 1 year (preferred)