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Pharmacovigilance / Drug Safety

PV Safety Risk Lead

Details

  • Full-time contract position
  • ASAP start for minimum 12 month contract
  • Work remotely in the UK
  • Competitive hourly rate of pay
  • Global pharma company

The Role

The Safety Risk Lead (SRL) will perform proactive Safety Surveillance (SS) and Risk Management with focus on signal detection and evaluation, risk assessment and safety risk minimization.

  • Provides disease area specific pharmacovigilance expertise, and applies this to various business unit products
  • Ensures consistency of Safety Risk Messaging for a particular product or class of products, across multiple indications/BUs within the many safety reports and communications for that product. Providing suitable summaries of product risks to summary document authors where appropriate, for example providing medical content/B-R statements and overall risk messaging of the safety profile to WMS/PSSR Authors.
  • Performs ad hoc special scholarly Safety Surveillance & Risk Management activities, rapidly, to meet specific needs in the BUs, such as RRT deliverables/emerging safety issue white papers/product Due Diligence Assessments.
  •  Identifies opportunities for Consistency and Standards for Safety Surveillance & Risk Management approaches and processes within a DA-Cluster and across BUs, and supporting the piloting and implementation of such.
  •  Innovates, champions and implements novel approaches to Safety Surveillance & Risk Management across BUs: engages in Continuous Improvement initiatives, Safety Sciences Research & Communications activities, including methodological improvements.
  • Engages in inspection readiness and support. Provision of data to project managers for metrics and activity tracking.
  • Frequently independently performs evaluation of all sources of safety data, identifies and independently analyzes safety signals, and presents evaluation of safety signals and benefit risk assessments to the appropriate forums.

Full job description available on application

The Candidate

  • Education: MD (physician) degree, PharmD (pharmacist) or PhD
  • Minimum 5 years of: medical (e.g. patient care, clinical trial experience/investigator, academic medicine, specialty training and/or board certification), and/ or scientific, and/or pharmacovigilance or and/or drug development experience required.
  •  Disease Area specific knowledge is preferred.
  • Thorough understanding of Safety Risk Management internal and external environment, including applicable regulations and guidances.
  • Clinical development and post-marketing experience to have an understanding of safety context across the drug lifecycle.
  • Only candidates with existing right to work in the UK/EU will be considered

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