Pharmacovigilance
3 weeks ago
A pharmacovigilance associate ensures compliance with applicable regulations or standard operating procedures; specialises in drug safety management, clinical trials and medical supervision.
- Responsible for conducting, monitoring or reporting regular pharmacovigilance developments and supervising the processes related to ensuring drug effectiveness and avoiding adverse effects or side effects of marketed pharmaceutical products among the general population in research trials and hospitals.
- Pharmacovigilance associate aim at reducing the risks associated with administering and prescribing drugs along with improving safety and treatment outcome in patient care.
- The role includes activities of important case report follow-up; processing and writing adverse event programs; serving link between the company, healthcare experts and patients for delivery of valid information on product safety;
- Conducting and supervising regular pharmacovigilance processes; attending several product safety meetings and adding functionality to product safety.
- A pharmacovigilance associate monitors all products and conducts post-market evaluations to ensure drug safety. These experts are actively involved in assessing adverse event writings, updating reports on safety, conducting quality and conveying drug related case reports to appropriate authorities.
- Pharmacovigilance Associate plays an important role in research, development and testing of new medications in the pharmaceutical industry.
- Responsible for global pharmacovigilance activities to support data safety and case tracking; perform document archiving; assist in the administration of pharmacovigilance meetings; support quality of review documents and initiate business liaison.
- Other essential duties include drafting pharmacovigilance agendas and meeting minutes; accurately archiving pharmacovigilance documents; reviewing safety case data and other pharmacovigilance documents for completeness and accuracy; monitoring periodic safety reports through quality review of safety data and project management; assisting with tracking, submitting and distributing of periodic reports; assisting liaisons with the partners and cross-functional team members to ensure compliance; supporting various ad-hoc deliverables or pharmacovigilance projects; and conducting regulatory inspections.
**Benefits**:
- Internet reimbursement
Schedule:
- Day shift
Ability to commute/relocate:
- Pune, Maharashtra: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work: 1 year (preferred)
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