Dr. Reddy’s Laboratories Ltd., established in 1984, is a globally recognized pharmaceutical leader committed to accelerating access to affordable and innovative medicines. Headquartered in India, the company operates in 66 countries with state-of-the-art manufacturing and R&D facilities, employing over 24,000 professionals. Driven by the motto “Good Health Can’t Wait,” Dr. Reddy’s emphasizes sustainability, operational excellence, and innovative healthcare solutions.
Responsibilities for the PV Associate – EUG Operations Role
As a PV Associate in EUG Operations, you will play a critical role in ensuring compliance with pharmacovigilance activities across Europe. Your primary responsibilities include:
- Product Management and Compliance:
- Maintenance of the master product list for Europe and its reference product list.
- Drafting and managing SOPs, deviations, CAPAs, and conducting effectiveness checks.
- Regulatory and Operational Support:
- Supporting the Qualified Person for Pharmacovigilance (QPPV) with training and implementation of new PV activities per updated guidelines.
- Assisting in Periodic Safety Update Report (PSUR) submissions.
- Sharing updated Marketing Authorization (MA) statuses, SmPCs, and PILs with call centers and vendors for routine activities.
- Collaborative Efforts:
- Managing Eudravigilance access.
- Engaging in cross-functional alignment to address EU PV activities and ad hoc requirements.
- Process Improvement:
- Participating in process standardization and improvement initiatives under the supervision of the EU/UK QPPV.
Qualifications and Experience
- Educational Background: B.Pharm/M.Pharm degree is mandatory.
- Experience: 4–5 years of pharmacovigilance experience with exposure to global PV teams, especially in EU/UK operations.
Desired Skills
- Excellent teamwork and interpersonal communication skills.
- Strong organizational and time management abilities.
- Proficiency in MS Word, Excel, and PowerPoint.
- Relationship management experience with vendors and stakeholders.
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