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 / Berkshire, England
Global Clinical Research Director - Neuroscience An opportunity to join a growing small-mid sized pharma with a global presence in multiple therapy areas. This role specifically focuses on the development of products in Neuroscience, which is a key area for the company and means your role is highly visible to senior internal R&D leaders. As a Director in this therapy-focused clinical development team, you will devise and deliver clinical development plans for early phase global studies, and work closely with clinical project teams and regulatory colleagues. Core duties include: Provide high levels of medical and scientific insight for the Neuroscience group, strategically advising and guiding operational colleagues across clinical trial projects Manage execution of early phase clinical plans and protocols globally - especially for clinical trial sites in Europe Partner with global teams in the likes of Regulatory, Discovery Medicine, Drug Safety, Medical Affairs, and Business Development, to provide on-going medical support for clinical programs Help define and deliver medical guidance on compliance with GCP across all clinical development projects and framework Provide additional medical and scientific support to local, regional, and global teams assessing new product/indication acquisition opportunities within the Neuroscience group Candidate requirements include: Qualified physician Expertise in Neurology from clinical medicine or pharmaceutical medicine, ideally both Significant industry experience in clinical development Early phase clinical trial experience Global experience is highly desirable, however not necessarily essential Prior exposure to working directly with Regulatory teams on clinical trial projects 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 / 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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