Assistant Manager - Pharmacovigilance

Position Details:

Designation: Assistant Manager

Function: Pharmacovigilance

Location: Navi Mumbai

Role & responsibilities:

• Supporting in IT computer System validation activities of Safety Database and PV related applications
• Oversight activities for Pharmacovigilance activities, assess & Implement PV Regulatory Intelligence
• Managing ICSR Case processing activities, Procedural documents updates
• Participating in Internal and External Audits & Inspections preparations, mocks and presentation
• Perform oversight on vendor activities, SLAs and KPIs
• Knowledge of Aggregate Reports, PV Agreement life cycle management, Reconciliation & Regulatory Intelligence
• Knowledge of PSMF, Literature screening, Affiliate Management
• Support other operational activities related to Global Pharmacovigilance as required
• Contribute towards continuous improvement of PV systems and processes

Educational Qualifications:

Preferably M-Pharm/ MBBS/BHMS/BAMS

Post Graduate Diploma in Clinical Research Pharmacovigilance is preferred

Experience:

• 8 - 12 years of relevant experience
• Prior ICSR, Vendor Management, safety database experience in Argus or other platform
• Working knowledge of global EU, US regulations, ICH and GCP Guidelines and MedDRA
• Must be proficient in MS Office Suite, Computer system validation activities

Knowledge and Skills (Functional / Technical)

• Fluent in Medical terminology.
• Ability to prioritize and multi-task successfully in a fast paced environment.
• Ability to interpret and follow regulatory guidelines.
• Ability to react constructively in a high-energy and fast paced environment.
• Excellent project management skills with the ability to align internal and external resources.