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
Capital of the UK, home to the Big Ben, the British Museum and Buckingham Palace, London is one of the most famous cities in the world. With more than 2000 years of history behind it, London is filled bursting with iconic buildings, bridges and people.
With more than 170 museums, and over 300 languages spoken by its residents, London is known for being one of the most culturally diverse cities in the world. The British Museum alone contains more than 13million artefacts from the ancient world. If that’s not enough, there is also the National Gallery, the Tate Modern, the Natural History Museum and the Southbank Centre to explore – many of which are free entry, with reasonable admin charges for special exhibitions and events.
London may not be the largest city in the world, but it makes the most of the space it does have - Hyde Park alone offers everything from free yoga to fully fledged music festivals. Whether you want to wander through Camden Market, see Shakespeare’s Globe or catch a Clipper across the Thames… you’ll be hard pressed to run out of things to do - from street food to fine dining, the West End to the IMAX, London has a plethora of *activities to suit any budget.
London is constantly evolving – illustrated by its ever-changing skyline – and the
London job market is booming. In addition to being one of the world’s most significant financial and cultural capitals, London has one of the largest concentrations of universities and higher education institutions in the world – nurturing our future workforce.
Permanent / London, England
Job title: Global Medical Advisor - Oncology A rapidly growing pharma company in Central London is looking to hire an experience pharmaceutical physician to act as medical lead for a key asset. The role would work at a global level and have autonomy over strategy and execution for several products. You will work closely with senior leadership and have exposure to CMO, CEO level discussions. Responsibilities: Strategic Medical Affairs leadership for a given product, products or designated therapy area Act as strategic medical affairs advisor to the respective commercial business unit and works cross-functionally with other internal partners to provide product/therapy area medical expertise across all business areas Coordinate launch planning activities for key product(s) of strategic interest; develop key medical data summaries / presentations and the like to ensure successful market preparation for new products. Undertake expert assessment of new products / value add medicine opportunities and provide expert medical insights and analysis for key product acquisition and development projects. Identify and engage with key external experts within given product/therapy area, so as to ensure that external insights inform medical affairs strategic plans, and internal development opportunities; identify key medical trends and emerging issues with respect to a given therapy area and inform project teams as necessary. Requirements: GMC registered physician ABPI final signatory and previous medical affairs experience Having worked at regional, European or global level would be advantageous Strong communicator and ability to support cross functional groups Salary and benefits: A highly competitive salary and wider benefits scheme is on offer
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Permanent / Reading, Berkshire
Job title: Senior PV Officer A global Pharmaceutical company in Berkshire are seeking a Senior PV Officer to join their growing team. This role is responsible for the activities relating to pharmacovigilance for all company products, provide training in matters of drug safety & medical/product information and ensure that the company is compliant with relevant MHRA/EMA regulations. Responsibilities: Processing of Individual Case Safety Reports and ensure timely completion of all case processing activities in line with local regulations and company requirements. Working in collaboration with Global Patient Safety team on case management activities. Conduct PV activities in line with regulations and Company SOPs and comply with the ABPI Code of Practice Maintain awareness of PV regulatory requirements and developments. Requirements: Strong PV experience in the pharmaceutical industry. Experience in liaising with the MHRA/HPRA. Ability to work autonomously and show initiative. A life sciences degree would be beneficial. Salary and benefits: A highly competitive salary and wider benefits scheme is on offer. If you would like to apply then please email your CV to Freddie.hill@pharma-partners.net
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