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.
Education: B.Pharm/ M.Pharm with 8+ years of experience.
- Good working knowledge of EU and UK PV regulations
- Performs timely coordination of safety information dissemination
- Excellent teamwork and interpersonal skills Excellent time management and organizational skills.
- Good knowledge of computer applications and software, including MS Word, Excel, PowerPoint etc.
This role is a part of Pharmacovigiliance for EUG & will be based in Hyderabad location.