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 / Berkshire, England
UK Medical Director - Gene Therapy Pharma-Partners is working exclusively with a growing biotechnology business which has an exciting pipeline of gene therapy treatments across multiple therapy areas. This organisation will launch its first product in 2021. The UK will be a leading territory in Europe as this first product is launched and subsequent team expansion is executed. Working in a small UK operation as part of the country leadership team you will drive affiliate pre-launch medical activity. You will engage with senior external stakeholders (HCPs/KOLs) in the disease area, communicate directly with external regulatory authorities, and represent the UK as part of the wider European medical affairs structure as it executes globally agreed strategic plans. Beyond medical affairs you will also closely support decision-making for local Market Access and Regulatory Affairs activities, by collaborating with departmental heads and their teams. This opportunity reports into regional medical affairs, though will have a strong working relationship with the UK General Manager. Responsibilities: Development and subsequent execution of local medical affairs strategy, which includes ensuring the medical/scientific credibility and integrity of all activities conducted within the affiliate Acts as the senior leadership figure for country medical affairs decision-making Development and proactive maintenance of key scientific relationships with national Key Opinion Leaders (KOLs) and Healthcare Professionals (HCPs) within the disease area, as well as payors and reimbursement authorities Ultimate responsibility for medical input to Health Technology Appraisals (HTAs), working in very close collaboration with colleagues in Market Access and Regulatory Affairs Represent the organisation as appropriate at national, regional, and international meetings and congresses Requirements: Qualified physician with full GMC registration Significant post-qualification experience in clinical medicine in the NHS or equivalent Significant experience in medical affairs in the pharmaceutical industry Experience of product launch and ideally leading decision-making on local pre-launch medical affairs strategy (to include contributing to / leading on HTA submissions) An ABPI Final Medical Signatory is essential Experience working with Orphan drugs or in gene therapy is a "nice to have" and not a must Someone who is happy with daily variety and a challenging fast-paced environment This company promotes an extremely collaborative culture, so this person needs to be able to not focus on hierarchy and be happy involving themselves in work at both operational and strategic levels You need to be able to continually communicate effectively with people at different levels across different teams 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 / 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 / Berkshire, England
Medical Advisor Pharma-Partners are currently collaborating with a specialist pharmaceutical company to hire a Medical Advisor. With a strong, diverse portfolio in specialty medicine this is a great opportunity for an established medical/scientific affairs professional to join the business at a pivotal growth stage. Key Responsibilities Represent the affiliate's medical/scientific voice of expertise for assigned product(s) and relevant therapeutic areas. Provide medical / scientific expert advice / guidance to key customers for assigned products and relevant therapeutic areas, including scientific exchange and professional relationship development with key thought leaders / external experts. Provide medical / scientific input into Medical Affairs strategies for the affiliate medical department and commercial plans, as required, and medical / scientific support for medical department activities under the overall direction of the Affiliate Medical Director Provide medical affairs support to cross-functional affiliate teams Ensure that the medical affairs role is fully integrated to support the strategy and execution of affiliate business, while being functionally independent. Candidate Requirements: Medical Degree or Pharmacy degree Previous experience of working in a medical affairs role is essential. ABPI final signatory Experience with diverse therapeutic areas would be an advantage Excellent written and spoken communication and presentation skills. Salary and Remuneration: This role is offering a competitive remuneration package. 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 / 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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Permanent / Illinois, USA
Medical Science Liaison - Oncology - Midwest (IL, WI, IN, MO) Pharma-Partners is working with a small specialty pharma business focussed on improving patients' lives who suffer from rare disease by developing and commercialising products in areas of unmet need. As part of a new team build our client is seeking a Medical Science Liaison (MSL) to join their field Medical Affairs team to cover the Midwest. The MSL will play a key role in the launch of a new Oncology drug. Key Responsibilities: Develop and maintain successful relationships with KOLs and HCPs Provide scientific expertise and technical support to Key Opinion Leaders Regularly present scientific and clinical data in field meetings and at events Share relevant insights within medical and cross-functional teams Work with office-based colleagues in Medical and Brand teams, as well as other field-based colleagues, to provide scientific support and education for the company's products Ensuring adherence to company SOPs and medial compliance Attend relevant events across the Midwest The Candidate: Educated to advanced degree (PharmD, MD, PhD or equivalent) Must have experience as an MSL in the US Must have a background in Oncology and ideally an established network across the Midwest Demonstrable experience in managing key internal and external relationships Can effectively assimilate scientific and clinical data to the relevant audience Ability to travel at least 60% of the time Remuneration: Competitive basic salary and benefits package (including shares) To Apply: 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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