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Pharmacovigilance Officer

Ergomed
Ergomed
0-2 years
Not Disclosed
10 Feb. 22, 2024
Job Description
Job Type: Full Time Education: Any Graduate Skills: Communication Skills, Interpersonal Skill, Technical Skill

Job description

 

  • The PV Officer should be a Life science / bio medical background graduate or have other healthcare related degree qualification (chemistry, biology, biotechnology, veterinary science etc) and have demonstrated experience in case processing
  • The PV Officer will be working as part of a project team, performing, and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance
  • PV Officers are expected to reach and maintain a high level of performance within 3 months of being assigned to an ICSR team, following onboarding completion

 

Responsibilities include:

  • 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. As a key member there is an expectation to 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


 

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

  • Demonstrated case processing experience

  • ARGUS experience preferred

  • 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

Role: Medical Record / Health Informatics

Industry Type: Pharmaceutical & Life Sciences

Department: Healthcare & Life Sciences

Employment Type: Full Time, Permanent

Role Category: Health Informatics

Education

UG: Any Graduate

PG: Any Postgraduate