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
Permanent / Hertfordshire, England
Job title: Senior Pharmacovigilance Manager (Northern Europe) A global pharmaceutical business in Hertfordshire are seeking a Senior Pharmacovigilance Manager to support all products within Norther Europe. This role will also be responsible for the line management of a PV Manager. Responsibilities: Overall responsibility for PV within Northern Europe. To be the UK contact person and local expert in PV by keeping abreast of current best practice and future developments. Notify GPV and update local standard operating procedures (SOPs) with any changes in UK PV legislation or national requirements. Liaise with Pharmacovigilance personnel regarding initial reports of adverse events so that these may be reported in line with statutory requirements. Communicate changes on product SPCs and PILs to external bodies; alert BNF, MIMS, C&D, PJ and UKMI to changes to Product Licences and SPCs, update SPCs and PILs on eMC website, communicate changes to internal customers, maintain the abbreviated prescribing document for promoted products. Review promotional material in line with Code of Practice; review materials for technical accuracy and correct referencing in line with internal SOP, assist with preparation of data for defence of CoP complaints, as required Requirements: Medical, Pharmacy, Nursing or Life Science Degree is essential Significant Pharmacovigilance experience within the pharmaceutical industry Prior line management experience is desirable Salary and benefits: To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk
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Permanent / London, England
Medical Director - UK & Ireland Pharma-Partners is working with a small/mid-sized specialty pharmaceutical business with a diverse portfolio across multiple therapy areas as they look to recruit a new UK & Ireland Medical Director. Reporting into EU Medical and as the most senior medic for the affiliate, this position is responsible for developing and implementing country level strategy whilst providing medical and scientific expertise to colleagues. The Medical Director is part of the affiliate leadership team and will input into key cross functional projects. In this role you will manage a small team including Medical Advisors, MSLs, Medical Information and Pharmacovigilance. This opportunity is open for a first time Medical Director providing you are a UK registered Medical Doctor, have Medical Affairs line management experience, and have worked as a Therapy Area Head, Head of Medical Affairs, Medical Lead/Manager or equivalent. Role Responsibilities: Provide medical leadership to activities across the UK & Ireland Member of affiliate Leadership Team Line manage, coach and lead the medical department Development of medical affairs strategy in collaboration with business partners and regional teams Direct post-marketed Clinical Research activities Oversee Pharmacovigilance and Medical Information activities Develop influential relationships with KOLs Ensure high standards of compliance across the business Candidate Requirements: Medical Doctor (must be GMC registered) Significant amount of pharmaceutical industry experience in Medical Affairs Demonstrable competence in and understanding of Medical Affairs strategy Proven leadership and line management skills Effective communicator Salary & Remuneration: Competitive basic annual salary plus a benefits package to include car allowance and annual bonus scheme 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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Permanent / London, England
Medical Director - Clinical Development - Endocrinology Pharma-Partners is working with a fast-growing Global CRO to help increase the medical expertise of the business in certain key therapeutic specialties. This organisation has expanded organically and has an operational office presence in multiple countries across the globe. A large proportion of the clinical research projects they manage for biotech sponsors are in rare diseases, across different therapy areas, which means their medical leaders are truly involved in high-science and innovation. A Medical Director in this business is involved "top to bottom" activities, and will find you operating in a flatter more agile structure compared to larger CRO environments where decision-making can sometimes be less rapid. Acting as the therapeutic subject matter expert for global and regional clinical trials cross different phases, you will provide on-going medical expertise for: Clinical trial design and site selection Clinical Study Report creation (CSRs) Trial feasibility assessments Management of Medical Information Regulatory document assessment and submission Supporting Business Development teams, staying involved in proposal meetings and sponsor engagement Management of drug safety activities and medical monitoring responsibility Candidate requirements include: Qualified physician (local country registration required) Recognised specialist in Endocrinology (Board Certified or equivalent) Experience in clinical research in pharmaceutical medicine, either in a CRO environment or pharma/biotech setting Regional and/or global trial management experience Medical monitoring experience and an understanding of global drug safety best practice Ideally experience of providing medical support to business development activities, including bid defence Someone who enjoys a busy and fast-paced role Good experience managing multiple projects and challenges at one time 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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Permanent / London, England
Medical Director - Clinical Development - Nephrology Pharma-Partners is working with a fast-growing Global CRO to help increase the medical expertise of the business in certain key therapeutic specialties. This organisation has expanded organically and has an operational office presence in multiple countries across the globe. A large proportion of the clinical research projects they manage for biotech sponsors are in rare diseases, across different therapy areas, which means their medical leaders are truly involved in high-science and innovation. A Medical Director in this business is involved "top to bottom" activities, and will find you operating in a flatter more agile structure compared to larger CRO environments where decision-making can sometimes be less rapid. Acting as the therapeutic subject matter expert for global and regional clinical trials cross different phases, you will provide on-going medical expertise for: Clinical trial design and site selection Clinical Study Report creation (CSRs) Trial feasibility assessments Management of Medical Information Regulatory document assessment and submission Supporting Business Development teams, staying involved in proposal meetings and sponsor engagement Management of drug safety activities and medical monitoring responsibility Candidate requirements include: Qualified physician (local country registration required) Recognised specialist in Nephrology (Board Certified or equivalent) Experience in clinical research in pharmaceutical medicine, either in a CRO environment or pharma/biotech setting Regional and/or global trial management experience Medical monitoring experience and an understanding of global drug safety best practice Ideally experience of providing medical support to business development activities, including bid defence Someone who enjoys a busy and fast-paced role Good experience managing multiple projects and challenges at one time 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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Permanent / London, England
Medical Director - Clinical Development - Neurology Pharma-Partners is working with a fast-growing Global CRO to help increase the medical expertise of the business in certain key therapeutic specialties. This organisation has expanded organically and has an operational office presence in multiple countries across the globe. A large proportion of the clinical research projects they manage for biotech sponsors are in rare diseases, across different therapy areas, which means their medical leaders are truly involved in high-science and innovation. A Medical Director in this business is involved "top to bottom" activities, and will find you operating in a flatter more agile structure compared to larger CRO environments where decision-making can sometimes be less rapid. Acting as the therapeutic subject matter expert for global and regional clinical trials cross different phases, you will provide on-going medical expertise for: Clinical trial design and site selection Clinical Study Report creation (CSRs) Trial feasibility assessments Management of Medical Information Regulatory document assessment and submission Supporting Business Development teams, staying involved in proposal meetings and sponsor engagement Management of drug safety activities and medical monitoring responsibility Candidate requirements include: Qualified physician (local country registration required) Recognised specialist in Neurology (Board Certified or equivalent) Experience in clinical research in pharmaceutical medicine, either in a CRO environment or pharma/biotech setting Regional and/or global trial management experience Medical monitoring experience and an understanding of global drug safety best practice Ideally experience of providing medical support to business development activities, including bid defence Someone who enjoys a busy and fast-paced role Good experience managing multiple projects and challenges at one time 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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