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Pharmacovigilance Associate

2 weeks ago

Pune, India Bitwise Pharma Full time

Job description
- Provide high quality, balanced and timely information to requests for medical information from both internal and external customers.
- Maintain a database of Medical Information requests and responses.
- Develop and maintain current knowledge of products and disease states.
- Maintain references and other Medical Information resources.
- Receive and initially process product complaints; forward information to the Quality Assurance Manager.
- Review promotional material for adherence to advertising regulations and guidelines, and medical accuracy.
- Process adverse event information from clinical trials and spontaneous reports including clinical data entry into the electronic database.
- Ensure data accuracy, clinically valid case assessment, regulatory reporting status assessment, and follow-up is completed on pharmacovigilance cases.
- Report adverse events to the appropriate Regulatory Authorities, and clinical study personnel according to regulations and standard operating procedures.
- Maintain a log, compliance information and filing system for all pharmacovigilance cases.
- Provide pharmacovigilance training to internal staff, and external partners, as required.
- Actively participate in departmental and various cross-functional project teams that may include Regulatory, Sales and Marketing, and Medical Affairs.

**Salary**: ₹10,000.00 - ₹25,000.00 per month

**Benefits**:

- Internet reimbursement

Schedule:

- Day shift

Supplemental Pay:

- Performance bonus

**Education**:

- Bachelor's (preferred)