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 / Buckinghamshire, England
Job title: Regional Medical Director - Rare Diseases A global rare disease biotech are looking for a Regional Medical Lead to work on their leading marketed product. You will lead on regional strategy, matrix manage affiliate medical teams and work closely with key cross functional groups to ensure the deliver of medical activities. This role is a key member of the medical affairs leadership team and is a highly visible position within the growing organisation. Responsibilities: Act as a subject matter expert to the International Region Responsible for the development and execution of the medical activities within the International Medical Plan, and supporting in country medical activities when needed Responsible for ensuring the medical activities are aligned to the Global Medical Strategy for the disease area and product(s) Develop and lead International scientific educational programs and events for Healthcare providers in partnership with cross functional teams Develop and lead International scientific advice seeking events Establish networks with external experts to expand potential research opportunities aligned with the Global Medical Strategy and Key Areas of Interest, and seek medical insights to inform local and regional strategy Support Global Medical Operations and Country Medical Teams to deliver data generation activities including investigator-initiated research and company sponsored phase IV and or non-interventional research. Line manage 1 direct report and matrix manage regional affiliate leaders Requirements: MD or MPharm degree preferred Extensive experience in medical affairs at both affiliate and regional level required ABPI final signatory preferred Prior experience in rare diseases or a biotech environment would be advantageous Salary and benefits: A highly competitive salary and wider benefits scheme is on offer
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Permanent / Bristol, England
Senior Medical Information Associate Pharma-Partners are currently working with an international pharmaceutical company with a diverse product portfolio due to significant historic acquisition and licencing deals. This is an exciting opportunity to join a growing business and work in a close knit medical team, working across the PAGB and ABPI codes and on several different therapeutic areas. This position will manage aspects of a medical and technical information service, contribute to the development and implementation of optimal strategies and act as an internal medical expert for PAGB related products. Responsibilities: Answer complex enquires in response to questions about company products from HCP's, Sales Representatives and members of the public in accordance with ABPI and PAGB Ensure that all Medical Information enquiries are accurately recorded in the enquiry management system in accordance with department SOPs and legislative requirements To develop and maintain an in-depth knowledge of the product portfolio (both pharma and consumer healthcare) and provide technical expertise on the Codes of Practice, in particular PAGB Provide training and guidance to peers within Medical Information and the across the business, as required Ensure that promotional and non-promotional materials developed by the company is in accordance with the Codes of Practice and other applicable rules and regulations Conduct literature searches, analyse data, critically appraise clinical papers, produce reports, extract trends and themes Lead on key departmental and corporate projects and initiatives Deputise for the Medical Information Manager, take a lead on projects and work with a number of internal and external stakeholders The Candidate: Science degree - Bsc, Msc, PhD, MPharm or MD A minimum of 2 years Regulatory/Medical Information experience Working knowledge of the PAGB code Copy approval experience ideally 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 / West London, London
Medical Manager - Dermatology - UK & Ireland Pharma-Partners is working with a specialist pharmaceutical company to hire a Medical Affairs Manager for their UK & Ireland Medical Affairs team. This is a key role that is responsible for devising and implementing medical strategy for a selection of portfolio products and pipeline compounds. Our client has recenetly announced positive PIII results for a monoclonal antibody treatment and has plans to launch said biologic later this year. In addition to the existing pipeline, it is expected that the business will seek out acquisition opportunities to expand the offering and explore new ways to meet patient needs in the Dermatology space. Responsibilities: Develop and implement portfolio/pipeline strategy for assigned products Manage the designated UK&I medical budget Provide medical input into Market Access activities as required Support Marketing Team with brand planning Provide medical expertise for cross functional projects Functional leadership of MSLs for brands (not line management) Build and maintain relationships with KOLs Be a point of contact for and liaise regularly global colleagues Act as an internal scientific expert and provide training to colleagues where needed Review and approve materials in line with the ABPI Code of Practice Candidate Requirements: UK registered Physician or Pharmacist Must have Medical Affairs experience as a Medical Advisor (or equivalent) in the UK ABPI Final Signatory Cross functional project experience Strong communication skills Salary & Remuneration: This position can pay between £65,000 - 95,000 basic salary per annum (depending on experience) plus benefits package on top to include car allowance and annual bonus 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 / Hampshire, England
Senior Medical Advisor - Diabetes Pharma-Partners are currently supporting a leading global pharma company hire a Senior Medical Advisor for their significant Diabetes portfolio. This is a newly created position due to company growth and will be a key part of the Diabetes franchise. This role is suitable for an experienced physician currently working within diabetes looking to make their first move into the industry or someone already working in industry looking to take more of a leading role. The role will be part of a large team, work closely with internal and external stakeholders to execute the medical plan and work closely with multiple business functions providing key medical and clinical input into projects. Responsibilities: To provide medical expertise in Diabetes across the product portfolio To develop effective partnerships with relevant cross functional groups To develop effective partnerships with clinicians, other key influencers and external groups. To provide visible leadership to other members of the Medical Department and the broader UK business To contribute Medical Education activities which may include business planning, approval and certification of materials and joint working with other functions. Understand and anticipate the scientific information needs of all local/regional customers (payers, patients, health care providers) Contribute to the development of medical strategies to support brand commercialisation activities Offer scientific and creative input, contribute to the development, review, and approval of promotional materials for the brand team. Support training of sales representatives, and other medical representatives. The Candidate: GMC Registered Physician, ideally with clinical experience within Diabetes Previous Medical Affairs is preferred Effective communicator and team player Excellent presentation and project management skills Remuneration: Basic annual salary depending on experience plus a standard benefits 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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Permanent / Berkshire, England
Medical Advisor - Copy Approval (Final Signatory Required) Pharma-Partners are currently partnering with a leading biopharmaceutical company to hire two final medical signatories to support the delivery of compliant promotional and non-promotional materials within their haematology/oncology and speciality medicine divisions. With a strong, diverse pipeline and several key launches anticipated over the coming years this is a great time to join a growing business and have the opportunity to develop internally. Key Responsibilities Provide brand support for the preparation and final signatory approval of promotional and non-promotional material and activities. Support the continued implementation of a Code Compliant system for all promotional and non-promotional activities, ensuring the company is in line with ABPI standards, the MHRA blue guide for advertising and promotion and all applicable international Codes of Practice (EFPIA, IFPMA, and respective National Codes and National Regulatory Bodies) at all times. Provision of workable compliant solutions to support business development opportunities/product launches and contribute to the development of marketing campaigns Timely, accurate review and approval of materials in accordance with the relevant Codes of Practice. Provide Guidance to overseas affiliates and UK Affiliate as and when required Actively participate in cross-functional medical review projects to build medical review standard practices and solutions for the business Candidate Requirements: MD/MPharm that has experience as an ABPI final signatory is essential Experience working in a pharmaceutical industry across a range of therapeutic areas Attention to detail, used to working in a face paced environment and is a strong communicator Salary and Remuneration: This role is offering a competitive 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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