Dr. Reddy’s Laboratories, a leading multinational pharmaceutical company, is seeking a dedicated Pharmacovigilance Associate to join their team in Hyderabad. This role offers a unique opportunity to contribute to the company's mission of accelerating access to affordable and innovative medicines.
Job Details
- Position: Pharmacovigilance Associate
- Location: Hyderabad, Telangana
- Qualification: Bachelor's degree in Pharmacy
- Experience: 3-4 years in drug safety
About Dr. Reddy’s Laboratories
Founded in 1984, Dr. Reddy’s Laboratories has grown from a modest investment and 20 employees to a global presence with research and development centers, manufacturing facilities, and a commercial footprint in 66 countries. The company is driven by the purpose of making good health accessible to everyone, emphasizing access, affordability, and innovation.
Key Responsibilities
The Pharmacovigilance Associate will be responsible for supporting the Pharmacovigilance (PV) Quality Management System and associated training. Specific duties include:
- Drafting procedural documents including Standard Operating Procedures, Work Instructions and Guidance Documents to capture PV processes.
- Participate in the review, formatting and routing for review of procedural documents authored by other team members.
- Assist in the development of training materials for procedural documents as a mechanism for testing and documenting understanding.
- Support the development of training curricula for the global PV Team and affiliates, as applicable.
- Develop/deliver adverse event reporting training for non-PV internal teams and drug safety vendors on routine as well as annual basis.
- Perform and compile request for information (RFI) with PV data, adverse event collection, case processing, signal and risk management, clinical studies, PV safety concern/related issues, etc. The compilation of information to process PADERS.
- PADERS submission and publishing for all DRL products & acquired products.
- Regulatory correspondences by updating the PV shared drive labeling updates and send over to other PV stakeholders.
- Ensure provision of strategic information and complete PV Due Diligence for potential product acquisitions/divestitures and creation/modification of Safety Data Exchange Agreements.
- North America Product List for PV oversight including Master list, external & in-licensing products.
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Pharmacovigilance Associate Jobs in Hyderabad at Dr. Reddy’s Laboratories[/caption]
Additional Responsibilities
- Receive and independently triage adverse events received from other manufacturers via regular mail and/or dedicated mailbox and forward promptly for case processing.
- Responsible for compliance with executed Pharmacovigilance Safety Data Exchange Agreements (SDEA) and routine reconciliations.
- Support finance team in collating and processing multiple invoices from Safety as well as risk management program vendors.
- Maintains document security and integrity by filing the Pharmacovigilance documents in a secure room or sending indexed files to offshore archival.
- With minimal assistance, should be able to prioritize multiple projects, able to suggest solutions to complex issues, and delivers complete and accurate information within deadlines.
- Support North America and Global PV team with audits/inspection readiness.
- Perform all duties in accordance with Dr. Reddy’s business principles, corporate directives, SOPs and government and industry guidelines.
- Perform other relevant tasks as requested by management
Qualifications and Skills
- Educational Qualification: Bachelor's degree in Pharmacy
- Experience: 3-4 years of drug safety experience in the pharmaceutical industry with knowledge of global pharmacovigilance regulations.
- Technical Skills:
- Working knowledge of ICH-GCP guidelines and global regulations for PV, including FDA, Health Canada and EU
- Experience in drafting SOPs and Work Instructions and assisting in the preparation of training materials and e.g. quizzes to test SOP understanding
- With minimal assistance be able to take necessary decisions by applying FDA, HC, ICH-GCP and GPVP standard regulations/guidance.
- Proficient in MS Office: Word, Excel, & PowerPoint
- Behavioral Skills:
- Excellent communication skills for liaising with external stakeholders and internal teams.
Benefits and Work Culture
Dr. Reddy’s Laboratories offers competitive benefits, including personalized learning programs, relocation support, family support (maternity and paternity benefits), learning and development opportunities, and comprehensive medical and life coverage.
The company fosters a culture of empathy and dynamism, with a focus on helping patients lead healthier lives. Employees are supported by an enabling environment that promotes individual ability while fostering teamwork and shared success.
Apply Now
If you meet the qualifications and are passionate about contributing to a company committed to improving global health, apply online at
Dr. Reddy’s Careers.
https://pharmastuff.org.in/job/pharmacovigilance-associate-hyderabad-dr-reddys
