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Associate Director, Patient Safety Scientist

Job LocationGreat Abington
EducationNot Mentioned
Salary436.00 - 550.00 per day
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract , full-time Work from home

Job Description

* Associate Director, Patient Safety Scientist - Top Pharma -6 -month contract - Cambridge* This is an opportunity to further develop your pharmacovigilance (PV) experience in safety programmes, spanning the entire life cycle of drug development and peri-/post-submission. Our Scientists and Physicians play a strategic role in developing our medicinesand the safety science of the programme. The oncology pipeline, which includes novel combinations and modalities, provides an intellectual challenge to the safety teams, requiring a broad portfolio and scientific management approach to projects. Our teamsexperience develops as our portfolio does. My client is looking for an Associate Director, Patient Safety (PS) Scientist to join our Patient Safety department, working in the Oncology Therapeutic Area. In this exciting and challenging role, you will work collaboratively with the Global Safety Physician(GSP) and other PV Scientists and physicians. You will play a role supporting the safety strategy and requirements for your assigned drug project(s). Your ability to work collaboratively will facilitate cross-functional interactions with colleagues from acrossthe company, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams. As an Associate Director, PS Scientist, you will be involved in aggregating, reviewing, analysing and interpreting safety-related data to generate information to support safety decision-making by prescribers, patients and payers, with the ultimate goal of protectingpatients. You will apply your PV, oncology and scientific experience, knowledge and skills to deliver all aspects of safety documentation, including authoring and / or providing strategic safety input to regulatory documents, e.g., regulatory reports, healthauthority responses and the safety content of marketing authorisation applications. In order to apply for the Associate Director, Patient Safety Scientist contract, you should possess extensive experience in the field of pharmacovigilance within the Pharmaceutical industry, including all or majority of:

  • Clinical drug development (Early and/or Late Phase: develop & deliver programme level safety strategy, including proactive risk identification & mitigation planning)
  • Post-Marketing Surveillance (including signal detection & evaluation)
  • MAA/BLA submissions (preparation and authoring of the safety related aspects of the Common Technical Document)
  • Periodic Safety Reports (deliver strategy, preparation and authoring)
  • Risk Management Plans (deliver strategy, preparation and authoring)
  • Governance board interactions and communication across a range of activities
You will have demonstrated ability to handle more than one activity simultaneously, prioritizing well and recognising key issues, work effectively in an advanced matrix structure, understanding of epidemiology and have excellent communication skills bothboth written and verbal. Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK. This role can be remote working based in the UK.To apply for this position or if you want to discuss other roles that we are working on, please do not hesitate to contact Roberta Atkins on .

Keyskills :
PharmaceuticalPharmacovigilanceRisk Management PlansContractCambridgeInscopesignal detection & evaluationMAA/BLA submissionsPeriodic Safety Reports

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