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Pharmacovigilance Associate

1-3 years
Not Disclosed
10 May 1, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Description:

  • Name: PrimeVigilance (part of Ergomed PLC)
  • Established: 2008
  • Services Provided:
    • Medical Information
    • Pharmacovigilance
    • Regulatory Affairs
    • Quality Assurance
  • Global Presence: Europe, North America, Asia
  • Client Base: Small to large pharmaceutical and biotechnology partners, including medical devices.
  • Employee Focus:
    • Investment in training and development.
    • Emphasis on employee experience, well-being, and mental health.
    • Promotes work-life balance for employee satisfaction.
  • Mission: Making a positive impact in patients' lives.

Job Description:

Position: Associate Safety Data Management Specialist

Responsibilities:

  • Processing Individual Case Safety Reports (post-marketing and clinical trials) in compliance with regulations and client requirements.
  • Conducting reconciliation activities for all received reports.
  • Working under supervision and mentorship.

Qualifications:

  • Life science or biomedical background.
  • Previous experience in Data Entry or Quality Control.
  • Demonstrated experience in Pharmacovigilance case processing (2-3 years).
  • ARGUS/Aris G experience preferred.
  • Strong time management, organization, and multitasking skills.
  • Excellent interpersonal and communication skills.
  • Ability to work in the Pune office on a hybrid basis.
  • Advanced English skills (at least C1 level).

Additional Information:

Why PrimeVigilance?

  • Equal opportunities workplace with a focus on diversity, equity, and inclusion.
  • Human-centric environment fostering personal and professional growth.
  • Training and career development opportunities.
  • Supportive working environment with colleagues worldwide.
  • Core values include Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, Collaborative Partnerships.