The opportunity for a Pharmacovigilance Manager, with extensive RA background, has become available for a leading Pharmaceutical company!

Requirements:
B.Pharm/M.Pharm or related degree
Drug safety/Medicines Registration courses preferable
A minimum of 5 years Pharmacovigilance and Regulatory Affairs experience
At least 1 Year experience in management of all Pharmacovigilance processes ensuring total compliance with legislation

Responsibilities:
Establish, develop & maintain overall Pharmacovigilance (PV) systems
Strategize, manage & oversee drug safety operations
Single point of contact for all PV related activities for the company
Maintain & ensure application and adherence to local, regional & global adverse events (AE) reporting requirements regarding patient safety policies, processes and procedures
Compile and develop online PV training material & tracking that all company personnel have completed training bi-annually and received certificate upon successful completion of the assessment
Oversee company outsourced literature search activities for potential safety reports, review weekly and monthly reports
Author regulatory submissions & responses to Health Authorities
Built & manage PV team responsible for timely production of high quality output in accordance with applicable ICH guidelines, regulatory requirements & SOPs
Liaise with internal & external parties for project implementation, project-related information gathering; co-ordinate with cross-functional teams to ensure quality deliverables within agreed timelines
Assist New Business Development & Legal departments on safety-related issues required for preparation of proposals/ contracts for potential strategic partners
Collect, review, evaluate & process all AE reports for strategic partners products; including spontaneous reports, post-marketing surveillance & literature surveys
Communicate & correspond with appropriate individuals/ organizations to obtain initial and follow-up AE information
Review of regulatory guidelines and identification of impact on internal PV processes
Support licensing activities, regulatory authority inspections & internal audits
Assist Medical Advisors in monitoring safety profile of product
Involved in development & testing of safety systems/ IT applications & preparation of relevant manuals
Compile executive, board & strategic partners monthly reports using self-developed templates ensuring risks & issues arising raised timely
Continuous review, update & management of Safety Data Exchange Agreements (SDEA) & PV SOPs
Preparation of Line Listings and Periodic Safety Update Reports (PSUR)