Pharmacovigilance Scientist (safety Aggregate Report Specialist)

Ivivamedical

Serbia
**
Aggregate report authoring and review
Signal management and detection activities
Regulatory agency response documentation
** Ivivamedical is seeking a Pharmacovigilance Scientist specializing in Safety Aggregate Reports, to join their Lifecycle Safety Medical team in various countries across Europe and South Africa. The role involves authoring and reviewing aggregate reports, managing signal detection, and collaborating with various functional teams to ensure compliance with regulatory standards. **

Job Summary

  • The role serves as the principal owner for Safety Aggregate Report deliverables ensuring compliance with all applicable service level agreements.
  • Candidates will lead signal management activities including detection, validation, and evaluation analyses for post-marketing and clinical trial projects.
  • The position requires acting as a literature lead to identify ICSRs from literature and contribute to aggregate data review for marketed products.

Matching Summary

Match Score: 75

** Ivivamedical is seeking a Pharmacovigilance Scientist specializing in Safety Aggregate Reports, to join their Lifecycle Safety Medical team in various countries across Europe and South Africa. The role involves authoring and reviewing aggregate reports, managing signal detection, and collaborating with various functional teams to ensure compliance with regulatory standards. **

Skills & Requirements

Must-have

  • Aggregate report authoring and review
  • Signal management and detection activities
  • Regulatory agency response documentation
  • Literature safety surveillance leadership
  • Compliance with service level agreements

Nice-to-have

  • Mentorship of less experienced resources
  • Cross-functional team collaboration skills
  • Adaptability to new technology innovations
  • Strong organizational and time management
  • Self-motivated independent work style

Key Requirements

  • Bachelor's Degree in Scientific or Healthcare discipline
  • 1-2 years prior experience in drug safety or aggregate reporting
  • Knowledge of Standard Operating Procedures (SOPs) and medical terminology

Work Rights

Not specified

Tailored Resume

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