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pharmacovigilance physician
Key responsibilities: A Pharmacovigilance Physician is accountable forseveral operational and strategic responsibilities involved with the drug safety profile during development and when approved and marketed. Responsibilities include: Assessing AE events reported in clinical trials.Contributing to safety surveillance strategy and signal detection for individual assets, tracking and evaluating potential issues, including Investigator Sponsored Studies (ISS).Contributing to the development and updating of the Asset Safety Plans, Safety Management Plans, and Safety Study Specific Plans. Complete (DSURs), case narratives and any other safety medical documentation, contributing to high quality standard documents within the organization. Also a Pharmacovigilance Physician may be involved in external engagements depending on the seniority of the position, this will include contributing to medical and safety requests from regulatory agencies, preparing for audits and reviews and liaising with KOLs/ other experts in their field.In smaller organisations, where the role is more autonomous and spans outside of operational data management there may be more involvement with reviewing and interpreting scientific and clinical literature and competitor development information as well as being involved in review processes of essential documents (e.g. IBs, protocols, eCRFs, medical monitoring plans, PILs, informed consents).
Previous roles/experience would include:Pharmacovigilance Physician, Drug Safety Physician, Local Safety Officer, Clinical Research Physician
Usually reports into:Pharmacovigilance Medical Director, Safety Lead, Associate Director Pharmacovigilance, CMO, CSO, EU QPPV
Sits within this team:QPPV, Deputy QPPV, Pharmacovigilance Physician, Drug Safety Physician, Associate Director – Pharmacovigilance, Safety Lead, Local Safety Officer, Drug Safety Associate, Drug Safety Officer, Pharmacovigilance Manager
Qualifications:Medical Degree, MD, MBBS, MBChB, GMC Registration (UK).
Salary band:£50,000 - £100,000 Basic Salary, Bonus, Pension, Private Medical Care, Dental Care
Pharmacovigilance Physician jobs
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Senior Global Safety Physician - Neuroscience
Permanent / England
Senior Global Safety Physician - Neuroscience Location - UK Pharma-Partners are exclusively supporting a global specialty biopharmaceutical company to hire experienced Senior Global Drug Safety Physicians. The business has an extensive and focussed portfolio in this area with several ongoing clinical trials and approved marketed products. The successful candidate will have significant input into a wide range of safety activities, be part of a cohesive and experienced global team and have the chance to work on some key products both in development and approved across the globe. Key Responsibilities: Accountable for the conduct of safety surveillance and assessment of integrated safety information, to ensure the timely proposal of changes to the safety profile and appropriate risk management and risk minimization actions, in order to warrant the safe and effective use of products in development projects and on the market. Ensure effective proactive continuous management of the safety profile for assigned development compounds and marketed products, so that safety considerations reliably inform project decision-making, and all clinical development and life-cycle management safety milestones are met. Act as a member of the Global Product Team and Clinical Development Team for one or more products, as required and as delegated by the respective GPS TA Leader, and as such be the contact person for relevant safety-related deliverables, issues and questions in relation to this (these) product(s). Support the risk management activities for the respective TA products, ensuring high quality safety input for all benefit-risk assessments. Candidate Requirements: Registered Physician with industry experience within global pharmacovigilance/drug safety Knowledge of product development processes and experience of cross-functional team work Working knowledge of pharmacovigilance legislation Prior pharmaceutical or clinical experience in Neuroscience Fluent in written and spoken English Remuneration: The successful candidate will receive a highly competitive basic salary and remuneration package To apply for this position please use the "Apply" option or feel free to send your CV directly to the Pharma-Partners team via email info@pharma-partners.co.uk
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UK Medical Affairs Advisor - Neurology
Permanent / Berkshire, England
UK Medical Affairs Advisor - Neurology Pharma-Partners is assisting a medium-sized Global pharmaceutical business with a new hire for its UK medical affairs team focused on Neurology. The growing UK medical affiliate team is made of experienced medical professionals across all therapeutic teams, not just Neurology, and would be a challenging and dynamic environment in which Medical Advisor could learn rapidly. As the local medical lead for Neurology products you will work closely with commercial, regulatory, and market access colleagues to ensure medical & scientific expertise in shared and driven across the business. Becoming the medical champion for marketed brands is important, as is encouraging to the business' future successes by contributing to the medical analysis of in-licensing opportunities in the Neuroscience / CNS space. Responsibilities: Provide medical input into commercial decision-making for marketed and pre-launch Neurology products Help develop and maintain national relationships with Key Opinion Leaders (KOLs), Healthcare Professionals (HCPs), and other external stakeholders Provide efficient and ethical compliance guidance for all medical matters, in accordance with codes of practice (ABPI, IPHA) and internals SOPs Work with wider affiliate functions such as Market Access, Regulatory Affairs, Drug Safety, and Medical Information, to support the medical management of marketed and pipeline Neurology products Support senior medical affairs leaders, where appropriate deputising in internal cross-functional meetings and contributing to decision-making Requirements: Qualified physician or pharmacist (GMC/GPhC registered) Significant post-qualification experience in clinical medicine or clinical/retail pharmacy in the NHS or an equivalent setting Pharma industry experience in medical or scientific affairs over a number of years A current ABPI Final Medical Signatory would be "nice to have" though someone aiming to gain this will certainly be considered Therapy area experience in Neurology is desirable and not essential A confident communicator who can works in a changing cross-functional environment Someone who is up for a challenge and keen to learn quickly To apply for this position please use the "Easy Apply" option or feel free to send your CV directly to the Pharma-Partners team via email info@pharma-partners.co.uk
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