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 / 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
details
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
details
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
details
Permanent / West Midlands, England
Medical Science Liaison - Haematology - West Midlands, Wales & South West England Our client is a global biotechnology business with a history of work in the Rare Disease space and they're seeking a Medical Scientific Liaison (MSL) to cover West Mildands, Wales & South West England. This role sits in the Haematology team and will drive field based medical affairs activities for a couple of marketed and well known brands in Haemophilia. Working with complex Rare Diseases it will be critical that the successful candidate builds and maintains strong relationships with healthcare professionals across the territory and provides scientific support, training, and advice to cross functional teams internally. The Medical Affairs teams is headed by an experienced Pharmaceutical Physician and this particular role reports into the MSL team lead. Key Responsibilities: Be a field medical expert in the therapy area Provide scientific expertise and technical support to Key Opinion Leaders, ensuring the maintenance of credible and ethical relationships which allows them to access up-to-date medical and scientific information Share relevant insights within medical and cross-functional teams Support and deliver medical training of commercial field teams Identify opportunities for, and provide advice on Investigator Initiated Studies Focus on patient outcomes, develop local guidelines to support the use of the company's Haematology product Help to identify and establish relationships with new HCPs and KOLs across the assigned region Ensure adherence to company SOPs and medial compliance 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 Represent the business and medical team at local, regional and global congress and symposia The Candidate: University Degree level education in relevant scientific field, pharmacy, or similar (PhD candidates are desirable) Experience as an MSL in the life science industry is essential Experience in Haematology or Rare Diseases is preferred but not required Knowledgeable of the UK and Ireland healthcare systems Demonstrable experience in managing key internal and external relationships Effectively assimilate scientific and clinical data to the relevant audience 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
details
Permanent / Scotland
Medical Science Liaison - Haematology - Ireland, Northern Ireland & Scotland Our client is a global biotechnology business with a history of work in the Rare Disease space. Following an internal promotion they're now seeking a new Medical Scientific Liaison (MSL) to cover Ireland, Northern Ireland and Scotland. This role sits in the Haematology team and will drive field based medical affairs activities for a couple of marketed and well known brands in Haemophilia whilst also supporting the launch of new compound awaiting approval. Working with complex Rare Diseases it will be critical that the successful candidate builds and maintains strong relationships with healthcare professionals across the territory and provides scientific support, training, and advice to cross functional teams internally. The Medical Affairs teams is headed by an experienced Pharmaceutical Physician and this particular role reports into the MSL team lead. Key Responsibilities: Be a field medical expert in the therapy area Provide scientific expertise and technical support to Key Opinion Leaders, ensuring the maintenance of credible and ethical relationships which allows them to access up-to-date medical and scientific information Share relevant insights within medical and cross-functional teams Support and deliver medical training of commercial field teams Identify opportunities for, and provide advice on Investigator Initiated Studies Focus on patient outcomes, develop local guidelines to support the use of the company's Haematology product Help to identify and establish relationships with new HCPs and KOLs across the assigned region Ensure adherence to company SOPs and medial compliance 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 Represent the business and medical team at local, regional and global congress and symposia The Candidate: University Degree level education in relevant scientific field, pharmacy, or similar (PhD candidates are desirable) Experience as an MSL in the life science industry is essential Experience in Haematology or Rare Diseases is preferred but not required Knowledgeable of the UK and Ireland healthcare systems Demonstrable experience in managing key internal and external relationships Effectively assimilate scientific and clinical data to the relevant audience 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
details