PV Specialist - EUG Operations

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.