Deputy Manager/ Manager (Specialist- Pharmacovigilance)

Role & responsibilities

• Hands on experience setting up/ migration of pharmacovigilance safety database for management of ICSRs (clinical, & literature)
• Able to manage the PV system validation activities (IQ, PQ, and UAT)
• Extensive work experience on processing and review Individual Case Safety Report (ICSR)
• Knowledge on Safety Data Exchange agreements (SDEA), Pharmacovigilance Service Agreements, regulatory periodic benefit risk evaluation reports (PBRER), Addendum to clinical overviews (ACO), Periodic adverse drug experience reports (PADER), Canada Annual Summary Reports, Risk management plans (RMP)
• Extensive experience in handling regulatory inspections from various health authorities (US FDA, MHRA, EMA, Health Canada)
• Experience in handling pharmacovigilance agreements
• Supervising team level attrition analysis and forecast, handling resource management for the new region which includes managing resource utilization and performance management
• Capable of handling multiple tasks and priorities, self-motivated, displays initiative and ability to work independently as well as effective team player with strong interpersonal, communication, and strategic planning skills.
• Evaluating effectiveness of training & development programs; formulating or reviewing training strategy and determining appropriate instructional methodologies and formats

Preferred candidate profile

• Strong verbal, written and interpersonal communication skills.
• High level of accuracy and attention to detail.
• Excellent organization and prioritization skills; able to multitask.
• Thorough knowledge on Pharmacovigilance activities.

Interested applicants with relevant experience can also directly send profiles to hr@qpsbioserve.com