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Pharmacovigilance Associate

7 months ago

Remote, India Satyam Group Full time

**Job Summary**:
The Pharmacovigilance Associate plays a key role in monitoring and ensuring the safety of pharmaceutical products throughout their lifecycle. Working within a multidisciplinary team, the associate is responsible for the collection, assessment, and reporting of adverse events and safety information associated with medicinal products. This position requires meticulous attention to detail, adherence to regulatory requirements, and effective communication with internal and external stakeholders.

**Responsibilities**:

- Receive, triage, and process individual case safety reports (ICSRs) from various sources, including healthcare professionals, consumers, and clinical trials.
- Perform initial assessment of ICSRs to determine seriousness, expectedness, and causality, in accordance with standard operating procedures (SOPs) and regulatory guidelines.
- Accurately enter and maintain data in safety databases, ensuring completeness and compliance with regulatory requirements.
- Conduct thorough follow-up and data clarification activities with reporters to obtain missing or additional information related to ICSRs.
- Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, and Medical Affairs, to ensure timely and accurate reporting of safety information to regulatory authorities.
- Assist in the preparation and submission of expedited and periodic safety reports, such as Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports (PSURs), and Risk Management Plans (RMPs).
- Participate in signal detection activities, including data mining and trend analysis, to identify potential safety concerns and emerging risks.
- Conduct literature searches and review scientific literature for relevant safety information.
- Support pharmacovigilance audits and inspections, providing documentation and assistance as needed.

**Job Types**: Full-time, Fresher

**Salary**: ₹36,000.00 - ₹40,000.00 per month

**Benefits**:

- Health insurance
- Provident Fund
- Work from home

Schedule:

- Day shift
- Monday to Friday

Supplemental pay types:

- Overtime pay
- Yearly bonus

**Education**:

- Bachelor's (preferred)

Shift availability:

- Day Shift (preferred)

Willingness to travel:

- 25% (preferred)

Work Location: Remote

**Speak with the employer**
+91 8237213453