Drug Safety Associate

6 months ago


Ahmedabad Gujarat, India Vertex Business Solutions Full time

**Job Summary**:
As a Drug Safety Associate, you will play a crucial role in ensuring the safety and well-being of patients by monitoring and reporting adverse events associated with our products. You will collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, and Medical Affairs, to assess and manage safety information throughout the product life cycle.

**Key Responsibilities**:

- **Adverse Event Management**:

- Receive and review adverse event reports from various sources, including healthcare professionals, consumers, and clinical trials.
- Ensure timely and accurate data entry of adverse event information into safety databases.
- **Case Processing**:

- Perform comprehensive evaluation of individual case safety reports (ICSRs) to determine seriousness, expectedness, and causality.
- Collaborate with medical professionals to gather additional information and clarify details related to adverse events.
- **Regulatory Reporting**:

- Prepare and submit expedited and periodic safety reports to regulatory authorities in compliance with local and international regulations.
- Keep abreast of regulatory requirements and communicate changes to the team.
- **Signal Detection and Risk Management**:

- Participate in signal detection activities and contribute to the development of risk management plans.
- Collaborate with cross-functional teams to assess and mitigate potential risks associated with product use.

**Communication**:

- Provide timely updates on safety issues to internal stakeholders and external partners.
- Assist in the preparation of safety sections for regulatory documents and responses to health authority inquiries.

**Qualifications**:

- Bachelor's degree in life sciences or related field; advanced degree (MSc, PharmD) is a plus.
- Previous experience in pharmacovigilance or drug safety is preferred.

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

**Salary**: ₹15,588.34 - ₹35,584.55 per month

**Benefits**:

- Cell phone reimbursement
- Health insurance
- Paid sick time

Schedule:

- Day shift
- Monday to Friday
- Morning shift

Supplemental pay types:

- Performance bonus

Work Location: In person

**Speak with the employer**

+91 7385069412


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