Key responsibilities: The Pharmacovigilance Medical Director is a key position in the execution of safety strategies to ensure successful development for new drug entities globally. Leading Safety functions globally you will help to develop safety strategies, ensuring patient safety and regulatory compliance including for products that are in development and already marketed. You will also provide medical input to meet international regulatory requirements and company objectives. At times you will need to support the Qualified Person for Pharmacovigilance in Europe by contributing to the constant improvement of the company’s PV System. Other responsibilities include: Leading the preparation of Risk Assessments for company products, leading signal detection activities using data from all sources and bring medical expertise to drive Benefit Risk assessment report and support of other similar reports and actions. In addition you will need to contribute to the preparation and review of pharmacovigilance documentation for internal and external use by providing medical expertise to the preparation of responses to internal and external questions relating to the safe use of company products, safety issue works up etc. Also given the seniority of the position, external engagements are regular with KOL’s and regulatory bodies so it is highly important to maintain awareness of changes to regulatory guidance documents, requirements and state-or-the-art pharmacovigilance processes and make recommendations leading to the improvement of the effectiveness and profile of the department. Often you may need to meet with regulatory bodies or be subject to questioning/audits so the ability to communicate affective, present and build relationships with key external stakeholders is key.
Previous roles/experience would include:Pharmacovigilance Physician, Drug Safety Physician, Associate Director – Pharmacovigilance, Safety Lead, Local Safety Officer
Usually reports into:Vice President of Pharmacovigilance, Senior Medical Director Pharmacovigilance, CMO, CSO
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:£110,000 - £180,000 Basic Salary, Bonus, Car Allowance, Long Term Incentives, Share Options, Pension, Private Medical Care, Dental Care
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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Permanent / London, England
Medical Director - Clinical Development - Cardiology 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 Cardiovascular medicine (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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