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PrimeVigilance

Pharmacovigilance Officer (senior level position)

RemoteRomania only
Published
Experience
Senior
Employment
Full-time
Salary not disclosed
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Open to RO only. Set where you work from to check your eligibility.

No BS summary

Senior pharmacovigilance officer with several years of case processing experience and a life science/biomedical or healthcare-related degree. Must handle ICSR processing, SAE/SUSAR management, periodic reporting outputs, and mentor junior staff. Advanced English at least C1 required.

Required languages

English C1 Advanced verbal and written, required

What you'll do

  • Manage a variety of case processing services with full accountability.
  • Work as part of a project team, performing and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance.
  • Processing of Individual Case Safety Reports from all sources, including post-marketing and clinical trials, including device and combination products, in compliance with applicable regulations, PrimeVigilance procedures and client specific requirements and timelines.
  • Effectively cover all steps of a workflow cycle, except Medical Review.
  • Independent SAE/SUSAR Management, including submissions, unblinding and clinical trial reconciliations.
  • Preparation of database outputs for periodic reporting, including PBRER, DSUR, PADER, etc.
  • Mentoring and training of new and more junior employees within the department, including procedure optimization and development.
  • Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines.
  • Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations).
  • Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.).

What they require

  • Life science / bio medical background graduate or other healthcare related degree qualification, such as chemistry, biology, biotechnology or veterinary science.
  • Demonstrated experience with several years in case processing.
  • Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing.
  • Demonstrated case processing experience.
  • Time and issue management, delegation, organization and multitasking skills with good attention to detail.
  • Strong interpersonal and communication skills.
  • Advanced English skills, both verbal and written, at least C1.
  • Life science / bio medical background graduate or other healthcare related degree qualification (chemistry, biology, biotechnology, veterinary science etc.).

Benefits

  • Global reach and the chance to keep growing while you help protect patients.
  • Environment built on kindness, flexibility, growth and belonging.
  • Colleagues support one another and good ideas are heard wherever they come from.
  • You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
  • Global reach.
  • Chance to keep growing while you help protect patients.
  • You make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world.

PrimeVigilance is a global pharmacovigilance specialist helping clients navigate complex regulations and patient safety from early development through post-marketing surveillance.

PharmaceuticalsMid-size

What people say about this company

2.5/ 5

Salary not disclosed