POSITION DETAILSTitle: Pharmacovigilance ManagerUpward Reporting: Head of Quality and Drug SafetyPosition Type: Permanent, ongoing with a 6-month probation periodLocation: Egham, UKHours: Regular working hours are Monday to Friday from 9.00am to 5.30pm, with two days office attendance and three days remote working.Travel: Some international travel may be requiredABOUT THE COMPANYA global specialty pharmaceutical group focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening acute disorders, as well as healthcare solutions for the general population.DESCRIPTION OF THE ROLEResponsible for all processes and operating procedures to ensure compliance with appropriate regulations and quality standardsWork with the Head of Quality and Drug Safety and the EU QPPV to identify gaps with current processes, handle management escalation, as well as identifying possible resolutionsDevelop & manage Standard Operating ProceduresOversee case management and case handling, including providing back-up support for case handling staff where neededOversee safety database managementOversee signal detection and risk managementReview and approve Periodic Safety Update Reports (PSURs) and Periodic Adverse Drug Experience Reports (PADERs)Review and manage updates to Risk Management Plans, including liaising with clinical colleagues on post-marketing activities worldwidePSMF maintenance & updateInternal training of staff where necessaryEstablish key performance metrics to measure compliance and data qualityPreparation with relevant teams for any internal audits or regulatory inspectionsServe as the pharmacovigilance subject matter expert for internal audits and regulatory inspectionsResponsible for management of external pharmacovigilance service providers (i.e., national responsible/representatives)Develop Safety Data Exchange Agreements with Contract OrganisationsESSENTIAL REQUIREMENTS FOR ROLEBachelors degree or equivalent experience in science; Masters or PhD in pharmacy, biological science or related fieldExperienced professional with a strong background in pharmacovigilance who is passionate about safety in drug development/post-marketingProven track record in pharmacovigilance; extensive experience in CRO or pharmaceutical industryExcellent communication skills, both written and verbalProject management skillsIndependence and the ability to lead a team effectivelyObservational and analytical skillsGood time management and the ability to work to tight deadlinesAbility to problem solve and make decisions quicklyWHATS ON OFFER:A competitive salary with benefits.The chance to contribute and be part of a team whose work directly benefits healthcare and strives to improve peoples lives.A real hands-on opportunity to gain a high degree of commercial exposure.The chance to work alongside world-leading scientific experts.Working with highly-talented and dedicated colleagues in a fast-growing company that combines a focus on cutting-edge science with commercial delivery.
Job Title
Pharmacovigilance Manager