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A Fantastic opportunity for an experienced Pharmacovigilance Manager has become available within a leading Global Pharmaceutical company based in Buckinghamshire. As the Pharmacovigilance Manager you will act as the Regional lead for all Drug Safety and Pharmacovigilance activities within the UK. You will be accountable for ensuring safety activities are compliant to UK regulations and monitor domestic Adverse Drug Reactions from locally marketed and clinical products both directly and through the management of 3rd parties.
This position would suit an experienced Pharmacovigliance professional who can work independently with the ability to lead projects as well as supervise and train junior staff members.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Pharmacovigilance Manager will be varied however the key duties and responsibilities are as follows:
1. Individual Case Safety Reports ( ICSRs ) - You will review and triage Adverse Events ( AEs ) and prepare reports to be submitted to the MHRA, ensuring compliance is maintained. You will ensure you keep up-to-date on product knowledge and perform local literature reviews.
2. Development / Periodic Safety Update Reports ( DSUR / PSUR ) - You will provide input for the UK region to assist with PSUR and DSUR reporting as and when required to ensure Global reports are updated. You will also liaise closely with Regulatory Affairs teams to ensure Reference Safety Information is current and correct.
3. 3rd Party Vendors - You will negotiate and agree Pharmacovigliance Vendor Service Agreements with external suppliers while ensuring current vendors are reviewed and maintained. You will be expected to manage your vendors and ensure that their reports are reviewed to maintain compliance. You will provide training where required.
4. You will ensure that the Regional Pharmacovigilance Lead is provided oversight of the local Pharmacovigilance activities. You will ensure that SOPs are maintained and updated and author procedures where required.
To be successful in your application to this exciting opportunity as the Pharmacovigilance Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline (e.g. Biology, Chemistry, Pharmacology, Toxicology etc.) in addition to extensive Pharmacovigilance experience, ideally with experience of UK local authorities such as the MHRA.
2. Proven industry experience of Pharmacovigliance case reporting including Adverse Drug Reactions (ADRs), Adverse Events (AEs) and ICSRs in addition to experience of ensuring Pharmacovigilance compliance.
3. A working knowledge and practical experience with managing 3rd Party Vendors would be beneficial to your applications as well as experience of supporting local Responsible Person for Pharmacovigliance or QPPV.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.