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Pharmacovigilance Specialist - French Speaking

0-2 years
Not Disclosed
10 Oct. 24, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Grow with Us!
Are you eager to work in a dynamic environment where new challenges and opportunities are part of your everyday life? Then PharmaLex is the perfect career choice for you! As part of Cencora, the leading global service provider for the pharmaceutical, biotech, and medical device industries, PharmaLex specializes in effectively managing all aspects of regulatory needs, from early development to product maintenance.

Position: Pharmacovigilance Specialist - French Speaking

Location: Bulgaria
Language Requirement: French speaking professionals

Your Role

  • Safety Management:
    Manage safety-relevant information from various sources, including spontaneous reports, literature, clinical studies, and medical inquiries.

  • Case Processing:
    Handle data entry for cases, including translation between French and English, and perform quality checks on translations.

  • Literature Screening:
    Screen local scientific literature for safety-relevant publications and create search algorithms for effective literature screening.

  • Report Creation:
    Support the creation of Individual Case Safety Reports (ICSRs) for adverse drug reactions from clinical trials and spontaneous reporting, and ensure timely reporting to competent authorities.

  • Documentation:
    Document case processing at both the company and case level, and assist in generating, processing, and tracking follow-up requests.

  • Reconciliation and Tracking:
    Prepare and perform monthly reconciliations and maintain up-to-date pharmacovigilance trackers, including case trackers and monthly report trackers.

  • Translation Support:
    Provide translation support in case processing and ensure the quality of translations.

Your Profile

  • Education:
    Medical Documentation specialist or a degree in Life Sciences (or equivalent).

  • Experience:
    0-2 years of experience in pharmacovigilance, with a solid understanding of GxP and GVP regulations.

  • Knowledge:
    Excellent knowledge of legislative and non-legislative pharmacovigilance guidelines, along with familiarity with project-related SOPs (both internal and client-specific).

  • Skills:
    Strong organizational skills, project management abilities, and professional communication skills for interacting with internal and external clients.

  • Language Proficiency:
    Fluent in French and English, with exceptional written and verbal communication skills.

  • Personal Attributes:
    Ability to work independently as well as collaboratively in a team, with strong analytical thinking and flexibility to adapt to changing circumstances.

How to Apply

If you're interested in joining our PharmaLex team for this exciting opportunity in our forward-thinking company, please submit your application online. Include your earliest possible starting date, any visa requirements, and salary expectations.

For further information, feel free to contact us. We look forward to receiving your application!