REGULATORY AND PHARMACOVIGILANCE PRODUCT jobs in ENGLAND, United Kingdom #2

activities of an international portfolio of subcontractors, diverse and high-tech product portfolio As a Quality expert... necessary for the manufacture and release of batches such as Product Specification Files, Master Batch Records, Supply Chain...

safety signals. Contribute to the strategy and review of safety assessments and for signals or issues (including product... quality) or in response to Regulatory Authority requests. Lead the collection of material for periodic reports e.g. DSUR...

of senior management key pharmacovigilance findings Provides global medical leadership for product-focused safety activities... and initiatives based on deep understanding of good pharmacovigilance practices (GVP) and other regulatory guidance Participates in...

& medical review, handling of requests received from Central & Local Regulatory Affairs and PV departments) within respect... but not limited to collection of data, RMP writing and medical review, handling requests received from central or local regulatory...

processes and procedures related to but not limited to: Quality, Regulatory, vigilance, new product development and supplier... with other key functions; Commercial, Sourcing and Supply Chain, Regulatory, Pharmacovigilance and the local in market teams...

), and regulatory documents Communicates to senior management key pharmacovigilance findings Represents the Patient Safety... to effectively strategize and implement benefit-risk activities across the product lifecycle. The candidate will also provide input...

and Literature to join our leadership team in the Product Pharmacovigilance & Device Safety team, ideally based in our Raleigh... pharmaceutical industry, preferably in product pharmacovigilance & device safety teams. Versed in serving as a lead in ICSR...

of the business. You will understand compliance, regulatory and pharmacovigilance requirements. You will identify... new product launch readiness. You will be able to lead and motivate Medical and MSL teams in a fast-paced environment...