Job Description
Pharmacovigilance and Medical Information Manager
Neon Healthcare is a fast-growing and ambitious pharmaceutical company that develops, produces, markets, and sells prescription only medicines to hospitals, wholesalers, and retail pharmacies. Founded by entrepreneurs with a successful track in building pharmaceutical businesses, the company has significant operations in the UK and is looking to expand its activities into other markets.
Reporting to the Chief Technical Officer, this role supports the Pharmacovigilance and Medical Information Team with managing daily operations in compliance with regulatory requirements.
Description of Main Duties and Responsibilities
· Organise, manage and maintain a highly compliant Pharmacovigilance (PV) system for Neon Healthcare.
· Day to day management of the PV / MI Team (currently two direct reports).
· Ongoing monitoring of the safety profile of our portfolio of medicinal products and continuous overall safety evaluation during the post-authorisation period.
· Oversight of Individual Case Safety Reports (ICSRs), Standards Operating Procedures (SOPs), authoring aggregate reports (PSURs and PADERs) and Safety Data Exchange Agreements (SDEAs).
· PV SME for Risk Management Plans (RMP), Post Authorization Safety Study (PASS) protocols, Risk Minimisati...