Senior Area Safety Officer

il y a 3 jours

IssylesMoulineaux, Île-de-France Kelly Science, Engineering, Technology & Telecom Temps plein

Location:
Issy-les-Moulineaux, France (Hybrid)

Contract
: 12 months

Kelly FSP is looking for a skilled Senior Area Safety Officer to join our client's team and drive compliance, risk management, and product vigilance across local, regional, and global levels.

Your Impact:

  • Ensure compliance with safety regulations and internal policies.
  • Oversee product vigilance and risk management systems for all products.
  • Collaborate with global and local teams to deliver vigilance activities and respond to safety queries.
  • Support health authority inspections, audits, and business continuity planning.
  • Contribute to the ongoing development and improvement of safety data and procedural documentation.

What You'll Do:

  • Provide oversight of vendor resources and vigilance activities in scope countries.
  • Advise on updates to system master files and develop corrective actions for non-conformances.
  • Maintain thorough reporting and documentation practices.
  • Help train and maintain awareness of safety protocols for local teams.
  • Stay up-to-date on evolving safety regulations, supporting implementation of new requirements.
  • Translate and manage safety documents as needed.
  • Develop and update local procedures, ensuring alignment with global standards.
  • Support inspections, audits, and business continuity planning for vigilance operations.
  • Back-up the Area Safety Head as required.

Who You Are:

  • A health care science professional (e.g., pharmacist, nurse) with at least 3 years' experience in pharmaceutical safety.
  • Experienced in product vigilance roles within the pharmaceutical industry.
  • Able to work autonomously and organize workflow efficiently.
  • Knowledgeable on regulations and principles of pharmacovigilance, drug development, and product safety.
  • Skilled in relevant IT safety systems; fluent in English with excellent communication skills.
  • Proven collaborator, able to maintain strong relationships within the organization and with regulatory authorities.

This is your chance to make a meaningful difference in a dynamic and collaborative environment.

Ready for the next step in your pharmacovigilance career? Apply now and join us in promoting product safety and public health

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