Drug Safety Manager - Senior

Recruiter
ProClinical Ltd
Location
Buckinghamshire
Posted
08 Feb 2018
Closes
16 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
This Senior Drug Safety Manager job is with one of the most renowned global pharmaceutical, medical device and consumer health organisations located in High Wycombe. The organisation is a top 10 pharma company and employs over 100,000 professionals worldwide. Manage Drug Safety team members including, the UK Drug Safety Scientist, UK Drug Safety Associate and UK Drug Safety Administrator to ensure that Drug Safety Reporting activities are carried out in compliance with Good Pharmacovigilance Practice Regulations. Job Responsibilities: * Sign off memos in electronic system: 60% OF TIME CAPA implementation, effectiveness review and trending Support coordination of internal and external audits and inspections * To deputise for the Senior Drug Safety Manager when required. * Act as a key point of contact for studies or partner contracts Maintains oversight of aggregate reporting responsibilities, periodicity and submissions * Contributes to global, regional and / or local projects Write, review, validate and implement local procedural documents and verify adherence * Provide the office of the Qualified Person (QP) for pharmacovigilance any local information required to ensure compliance * Support Country Safety Team Lead (CSTL) in responding to ad hoc requests as required * Call Handling - answering in bound calls relating to patient data collection programs, third party partner contracts / agreements * Query handling - respond to queries escalated by the DSA / DSS / Senior DSS in a timely way obtaining input from CSTL / LSO as appropriate * Monitor regulatory websites and subscribe to relevant regulatory alerts to maintain continual awareness of regulatory changes that affects UK and Ireland and reports such changes to the CSTL / LSO to ensure compliance.Skills and Requirements: * Awareness of and familiarity with industry principles of drug development and pharmacology * Proficiency in global and local SOPs * Computer literate with expert knowledge of the Global Safety Database and/or expedited reporting module(s) * Ability to prioritise and work to strict timelines on a daily basis * Excellent verbal and written communication skills * Ability to negotiate and communicate with internal and external customers * Ability to work effectively as a member of the Drug Safety and broader Medical Department teams * Ability to establish and maintain open relationships within the organisation and with authorities * Knowledge and understanding of key legislation applicable to pharmacovigilance in the UK and Ireland Experience * Proven expertise and experience in pharmaceutical regulations and R&D processes is desirable Education * Degree-level qualification (ideally in life science) or equivalent nursing qualifications * Related Experience: 3 to 5 years To Apply:Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable. In case you have difficulty in applying or if you have any questions, please call Amy Quinn on +44 207 4400 633 or upload your CV on our website - www.proclinical.com. A full job description is available on request. ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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