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PrimeVigilance

Pharmacovigilance Officer (senior level position)

RemoteBulgaria only
Published
Experience
Senior
Employment
Full-time
Salary not disclosed
Check eligibility

Open to BG only. Set where you work from to check your eligibility.

No BS summary

Senior pharmacovigilance case-processing officer in Sofia with a life science/biomedical or healthcare-related degree. Needs several years of PV case processing experience and advanced English at least C1.

Required languages

English C1 required; advanced verbal and written.

What you'll do

  • 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.
  • Effectively cover all steps of a workflow cycle, except Medical Review.
  • Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations).
  • Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.).
  • Mentoring and training of new and more junior employees within the department, including procedure optimization and development.
  • Performing and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance.

What they require

  • Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing.
  • Demonstrated case processing experience.
  • Several years in case processing.
  • 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.

Benefits

  • Global reach.
  • Kindness, flexibility, growth and belonging.
  • Colleagues support one another and good ideas are heard wherever they come from.
  • Passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

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