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.