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pharmacovigilance physician
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
Pharmacovigilance Physician jobs
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Drug Safety Physician
Permanent / Maidenhead, Berkshire
Drug Safety Physician I am currently working with a leading, global vaccine company looking to hire an experienced drug safety/pharmacovigilance physician. This role is responsible for the medical expertise on all aspects of safety throughout the entire lifecycle of the assigned products. This individual will apply sound medical judgment for the analysis and interpretation of complex data for signal detection, substantiation and initiation of safety risk management activities including and not limited to risk minimization activities and evaluation of the effectiveness of risk mitigation measures. The role integrates these safety risk management activities of a given product, into the regulatory and business context. Responsibilities: Lead active monitoring and continued assessment of safety profile through systematic signal detection and critical review of single and/or aggregate safety data and literature during all phases of the life cycle of a defined portfolio of medicinal products. Lead the cross-functional Safety Management Teams regarding safety relevant topics and escalate all safety relevant matters to the appropriate decision making level with proposals for solutions based on analysis of the available information. Accountable for the appropriateness of the content of safety documents such as RMPs, PSURs, DSURs, and safety sections of CSRs, labelling documents. Interface with other departments (e.g. clinical development, regulatory and medical affairs, manufacturing and epidemiology) with regard to safety aspects of the given portfolio. In cross-functional setting, the BRMP is responsible and accountable for the following in the given products. Requirements: Qualified Physician with previous clinical experience Previous experience in Benefit-Risk Management and Clinical Trial Safety is required Exposure to Clinical Development and/or clinical safety of at least 1 product submitted to Regulatory Authorities for marketing authorization. Excellent communication skills, including formal presentation skills. Salary and benefits: A highly competitive salary and wider benefits scheme is on offer
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Associate Director Global Quality Management
Permanent / Buckinghamshire, England
Job title: Associate Director Global Quality Management The main task is the development and execution of the Global PV Audit Strategy and Global PV Audit Plan in close collaboration with the Global Lead, Global Quality Management. This includes defining risk standards and methodologies, audit methodology and best practices to ensure consistency of approach. Additional tasks are to support the continuous improvement of the Quality System, the inspection management, the regulatory intelligence activities, the SOP and WP management, the validation activities and the project liaison activities. Responsibilities: Ensure that a comprehensive Quality System is developed, in place and adhered to. Ensure continuous improvement and enhancement of the Quality System by supporting global metrics generation and 'lessons learned from audit/ inspection' Cover GxP related Functional Areas, specifically thus related to GCP, GVP, GMP and CSV. Identify process gaps and deficiencies in the Quality System, liaise and collaborate continuously with other Functional Areas and other partners for resolution Coordinate the preparation for GxP inspections Coordinate the responses to Regulatory Authorities Requirements: Degree in natural science or equivalent number of years experience Several years of clinical/industry/Regulatory Authority or otherwise relevant experience, preferably including Quality Management for Pharmacovigilance or Clinical Development or Computer System Validation Expert knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Pharmacovigilance, Clinical Development, Medical Device, IMP management, Regulatory Affairs and Pharmacovigilance Experience in Monitoring, Quality Assurance and/or Good Clinical Practices Qualification as an auditor Salary and benefits: A highly competitive salary, annual bonus and benefits package is on offer. 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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Senior Medical Advisor - Rare Disease (managing role)
Permanent / Cambridgeshire, England
Senior Medical Advisor - Rare Disease - UK & Ireland Our client is a global biotechnology business with a history of work in the Rare Disease space. In this Senior Medical Advisor role you will have line management responsibility for 1 MSL and effectively act as the medical lead for a new pipeline drug to be launched in 2022. Said drug has a further 3-5 indications in development which will be brought to market thereafter and thus you will lead on these launches too. The hiring manager is an experienced Pharmaceutical Physician and expects the succesful candidate to be in the Cambridgeshire office 1-2 days per week. This is a great opportunity for any candidates looking to take on line management for the first time. Key responsibilities: Develop and implement medical strategy for designated products Line manage the disease area team Manage budget allocation Establish and maintain relationships with KOLs Support Marketing in the development of the Brand Plan Provide medical expertise to Market Access colleagues as required Work with local and global teams on evidence generation plans and IITs Be the medical expert for the designated therapy area and provide internal training where necessary Strengthen medical education programs planning, content and execution Review and approve materials in line with the ABPI Code of Practice Key requirements: Physician or Pharmacist with ABPI Final Signatory experience Prior experience as a UK Medical Advisor Experience of working in Specialty Care Project management and leadership skills Excellent communication and presenting skills 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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Code Signatory - Business Partner
Permanent / Slough, Berkshire
Code Signatory - Business Partner I am currently working with a specialist pharmaceutical company looking to hire an experienced ABPI final signatory to maintain a high-quality Copy Approval system, whilst supporting the needs of the medical, commercial, marketing, and market access functions of the business. This role will be partnering with senior leaders in the organisation, will take an influential, proactive role in maintaining excellence regarding copy review and the code of practice. Responsibilities: Act as lead final signatory and review and certification/examination of promotional and non-promotional materials/activities Be responsible for co-ordination and allocation of all materials across all areas of interest and, working with commercial, marketing, market access, and medical colleagues (including other Code signatures) Lead the planning and prioritisation of materials through the Copy Approval system to ensure efficient delivery of all materials according to agreed timelines, and across all areas of interest to the business Maintain high standards in respect of quality of materials produced, efficiency of the Copy Approval processes, and ongoing development and training of all signatures. Work with key colleagues in marketing/commercial, or other functional areas, during the early development of materials to ensure items entering the review and approval system (Promo Mats/Veeva) are of sufficient quality to ensure an efficient flow through to certification/examination. Requirements: UK registered pharmacist or physician Significant medical review and ABPI code knowledge, experienced ABPI final signatory Excellent communication and leadership skills Salary and benefits: A highly competitive salary and wider benefits scheme is on offer
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Medical Manager - Dermatology
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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