Dr. Reddy’s Lab Hiring for Pharmacovigilance Associate
About the Company
Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company operating in 66 countries. With over 24,000 employees, we are committed to accelerating access to affordable and innovative medicines. Since our founding in 1984 with 20 employees, we have expanded to include research and development centers, manufacturing facilities, and a global commercial presence. Our mission: Good Health Can’t Wait.
Position Details
- Position Name: Pharmacovigilance Associate
- Organization: Dr. Reddy’s Laboratories
- Location: Hyderabad
- Salary: N/A
Qualifications
- Education: Bachelor’s degree in pharmacy
- Experience: 3-4 years of drug safety experience in the pharmaceutical industry
- Skills:
- Proficient in MS Office: Word, Excel, PowerPoint
- Knowledge of global pharmacovigilance regulations
- Working knowledge of ICH-GCP guidelines and global PV regulations (FDA, Health Canada, EU)
- Experience in drafting SOPs and preparing training materials
- Ability to apply FDA, HC, ICH-GCP, and GPVP standard regulations/guidance
Roles & Responsibilities
| Area | Responsibilities |
|---|---|
| Document Management | Draft procedural documents including SOPs, Work Instructions, and Guidance Documents. Review, format, and route documents authored by other team members. |
| Training Support | Assist in developing training materials and curricula for the global PV Team and affiliates. Deliver adverse event reporting training to internal teams/vendors. |
| Data Management | Perform and compile RFIs with PV data, adverse event collection, case processing, signal and risk management, clinical studies, and PV safety concerns. |
| Regulatory Correspondence | Manage PADERS submission and publishing for all DRL products. Update PV shared drive with labeling updates and communicate with stakeholders. |
| Strategic Information | Ensure provision of strategic information for product acquisitions/divestitures and create/modify Safety Data Exchange Agreements. |
| Compliance | Ensure compliance with SDEAs and routine reconciliations. Support finance in processing invoices from safety and risk management program vendors. |
| Audit Readiness | Support North America and Global PV team with audits/inspection readiness. Maintain document security and integrity. |
| Additional Duties | Perform other relevant tasks as requested. Prioritize multiple projects and deliver accurate information within deadlines. |
Skills & Attributes
- Technical skills in ICH-GCP and global PV regulations
- Proficiency in MS Office
- Ability to prioritize multiple projects and suggest solutions to complex issues
For more details, please visit our career website.
