Patient Safety Strategist

hace 3 semanas


Barcelona, Barcelona, España Morgan Philips Executive Search A tiempo completo

Important Pharmaceutical Company is a leading player in the industry, seeking an experienced Patient Safety Strategist.

Responsibilities:

  • Develop and implement proactive PV and risk management strategies for complex or multiple products.
  • Collaborate with cross-functional teams to prepare safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS).
  • Lead process improvement initiatives within the Patient Safety organization.
  • Serve as a key member of the Safety Strategy and Management Team, providing expertise on complex and/or multiple products.
  • Present intricate issues to the Safety Information Review Committee.
  • Develop and implement safety strategies for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs).
  • Leverage expertise to lead safety strategy for regulatory submissions of new products, formulations, or indications (NDA/BLA, MAA) with Global Safety Physicians and functional specialists.
  • Negotiate contracts/agreements with third parties to ensure quality and integrity.
  • Take accountability and resolve safety issues, mediating cross-functional agreements.
  • Participate in due diligence activities.
  • Provide training and mentorship to new team members in approved processes and systems.

Requirements:

  • Degree in life sciences or similar field.
  • Advanced experience in Patient Safety and/or Clinical/Drug Development.
  • Excellent written and verbal English skills.
  • Advanced knowledge of PV regulations.
  • Clinical Development (Early and/or Late Phase) experience.
  • Post-Marketing surveillance experience.
  • MAA/BLA Submissions experience.
  • Periodic Reports experience.
  • Risk Management Plans experience.
  • Governance Board Interactions experience.

Location: Barcelona, Spain. Estimated annual salary: €70,000 - €90,000 depending on qualifications and experience.



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