Pharmacovigilance Associate, Safety Data Management

alvotech.is

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Icsr/sae management
Regulatory submissions
Safety systems lifecycle management
** Alvotech is seeking a Pharmacovigilance Associate to join their Global Safety Data Management team, focusing on clinical safety and post-marketing pharmacovigilance activities. The ideal candidate will have a master's degree in pharmaceutical sciences and at least two years of relevant experience, with expertise in safety data management systems. **

Job Summary

  • The Pharmacovigilance (PV) Associate will be responsible for all assigned Clinical Safety and post-marketing PV activities within the newly developed, lean and efficient, Global Safety Data Management team.
  • The role focuses on Safety data management for clinical trials and post-marketing programs, including system setup, process optimization, and ensuring regulatory compliance with international law and regulations.
  • This position involves cross-functional collaboration with various internal departments and external partners, as well as delivering trainings on pharmacovigilance processes and standards.

Matching Summary

Match Score: 75

** Alvotech is seeking a Pharmacovigilance Associate to join their Global Safety Data Management team, focusing on clinical safety and post-marketing pharmacovigilance activities. The ideal candidate will have a master's degree in pharmaceutical sciences and at least two years of relevant experience, with expertise in safety data management systems. **

Skills & Requirements

Must-have

  • ICSR/SAE management
  • Regulatory submissions
  • Safety systems lifecycle management
  • Global Pharmacovigilance processes
  • Clinical trial safety
  • Post-marketing PV activities

Nice-to-have

  • Result oriented work environment
  • Comfortable in multicultural team
  • Experience with biologic and combination products

Key Requirements

  • Master’s Degree in pharmaceutical sciences or related fields
  • 2+ years in Pharmacovigilance/Drug Safety
  • Expertise in Safety systems (e.g., Argus, ARISg)
  • Proven track record with global Products and Clinical trials
  • Detailed knowledge of PV processes, directives, regulations and international guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter