Drug Safety Manager


Warsaw, Poland

Purpose of the Role

  • To keep senior management appraised of any potential or actual study/staffing issues and develop solutions for the same.
  • To project manage small to mid-size drug safety projects, including sponsor liaison, management of quality standards/timelines/budgets and development of safety plans, study specific procedures (SSPs) and workflows for clients.
  • To assist senior management with resourcing and business development activities, including attendance at bid defense meetings as requested.
  • To ensure audit readiness and/or represent MSS at audits.
  • To actively identify options for process improvement and develop/implement departmental training to develop supporting staff skills, encouraging growth and providing regular performance feedback.

Role Requirements

  • The successful candidate will have advanced, proven relevant clinical research/pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with thorough knowledge of global safety processes/regulations and medical terminology/coding systems as well as contract and proposal preparation/review.
  • Proven ability to lead study teams and manage/mentor staff.
  • The ability to interact effectively and professionally with various levels of staff for both internal and external departments, vendors and sponsors. Must be fluent in written and verbal English with good communication skills and excellent computer skills. Detail orientated and capable of working effectively within a team environment.
  • Medical/science background (nursing preferred) and/or bachelor’s degree or local equivalent.

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