Job Description

This role is responsible to support the EUG PV activities while performing below mentioned activities.

Responsibilities:

- Under the supervision of the EU/UK QPPV, managing the EU RMP and UK RMPs and their trackers.
- SmPC updates and Safety variation initiation, tracking.
- Handling of RMP queries, Cmdh intimation of risks.
- PSUR data collection and QC.
- ACOs data collection and QC.
- Tracking and Documentation: ensure all activities are tracked through the maintenance of activity tracking spreadsheets.
- Eudravigilance database handling and Signal detection.
- Regulatory Intelligence: Monitor PSUSAs and track the activities to be addressed in next PSUR.
- Post authorisation update of RMPs - initiation and its related variations tracking with RA.
- Deviation & CAPA Support
- Prior Audit and inspection experience.
- Any other activities assigned by reporting Manager.

Relationship Management

- Working with EU or UK PV team, Global PV team.
- Interactions with vendor’s/service providers for PV activities

Process Improvement / Standardization

- Participate in process improvement initiatives under supervision of UK/EU QPPV.

📌 PV Specialist - EUG Operations (Hyderabad)
🏢 Dr. Reddy's Laboratories
📍 Hyderabad