Returning Candidate?



Senior Director of Global Patient Safety
Job Locations 
US-PA-Blue Bell
United Kingdom-Swansea
Posted Date 

More information about this job


We are currently seeking an experienced Pharmacovigilance leader. Activities include overseeing the following, as applicable to drugs, biologics and devices throughout the life-cycle of a product, with a particular emphasis on post-marketed products.

  • Risk Management Plans (RMPs)
  • risk minimization activities
  • Risk Evaluation and Mitigation Strategies (REMS)
  • design and analysis of safety studies
  • epidemiology reports safety/risk management aspects of observational studies
  • label changes
  • signal detection and investigations
  • benefit-risk assessments


  • Leads a team of Safety & Risk Management experts
    • Manages performance and supports growth of assigned direct reports
  • Builds and aligns a technical team to perform critical operating tasks meeting or exceeding client and PRA expectations.
  • Supports the strategic and operational functions of the business unit Safety & Risk Management to meet its goals and project objectives.
  • Provides leadership and consultancy to clients and project teams delivering services in the areas of cumulative safety reports, benefit-risk assessments, epidemiology, signal detection and investigations, design and analysis of safety studies, risk management plans and risk minimization activities, pharmacovigilance audits and inspection preparation including generation of a project plan in close cooperation with project team.
  • Initiates and leads the development and implementation of processes, systems and tools to broaden service offerings and/or improve efficiencies in PRA’s safety & risk management services.
  • Member of Steering/Executive Committees as part of relationship governance, attendance of related meetings and resolution of escalated issues.
  • Participates in developing new and existing business by attending sales presentations and interacting with clients.
  • Creates an environment that encourages learning, self-improvement, and career development for staff.
  • Develops, implements, and delivers training for employees providing safety and risk management services, including cross-functional training.
  • Contributes to the implementation of sales & marketing strategies (e.g. for new service offerings or specific target clients).
  • Participates and presents at conferences.
  • Takes a lead role in growing PRA’s safety & risk management services through client retention, acquisition of new clients, expansion of service offerings, attraction of safety experts, staff development and strategic alliances.



  • Monitors projects within the business unit to assure PRA profitability, associated project goals and objectives of high quality deliverables are met.
  • Maintains familiarity with current industry practices and regulatory requirements that affect benefit/risk evaluations, NDAs/BLAs/MAAs, and changes to labeling and marketing authorizations.
  • Substantial experience in the pharmaceutical industry with significant experience in a leadership position in safety and risk management in industry-related clinical research.
    • Demonstrated experience in a line management role.
  • Proven history of successful involvement driving a strategic, global, cross-functional initiative.
  • History of successful in interactions with regulatory authorities, IRBs/Ethics Committees, medical community, knowledge of regulatory requirements for human drugs, biologics, and/or devices.
  • Proven history of leadership of business development initiatives.
  • Experience in preparing, implementing, and managing departmental operating plans.
  • Experience in process re- engineering.
  • An advanced degree (M.S. or Ph.D.) from an accredited institution in medicine, pharmacy or other life-sciences.
    • Postgraduate degree in epidemiology, statistics or public health or equivalent degree, preferred.
  • Excellent written and oral communication and presentation skills.
  • Reads, writes, and speaks English; fluent in host country language required.

LOCATION: This position can be located in the United States, Canada, Germany, the UK or another EU country. Options are available for a home-based or an office-based position in the locations noted.


PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.


Share on your newsfeed

Connect With Us!

Not ready to apply? We get it! Click here to stay in touch for future opportunities, events and other happenings!