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    Freelance / Consultant 0.5 Fte Local Contact Person For Pharmacovigilance And Regulatory Affairs (Lcppv/Lcpra)

    Primevigilance
    0-2 years
    Not Disclosed
    Remote
    10 Oct. 18, 2024
    Job Description
    Job Type: Full Time Remote 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

    Job Title: Freelance/Consultant - Local Contact Person for Pharmacovigilance and Regulatory Affairs (0.5 FTE)

    Location: Remote
    Employment Type: Full-time
    Department: Regulatory and PV Network

    Company Description

    PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. With a commitment to global organic growth, our team spans Europe, North America, and Asia, offering services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

    We pride ourselves on delivering exceptional support to our pharmaceutical and biotechnology partners, fostering long-lasting relationships, and establishing ourselves as a global leader in our field. Our expertise encompasses all therapy areas, including medical devices.

    Job Description

    We are seeking a freelancer/consultant to join our team as a Local Contact Person for Pharmacovigilance and Regulatory Affairs at 0.5 FTE. This role offers the chance to work in an international team and enhance your expertise in the diverse fields of Pharmacovigilance and Regulatory Affairs.

    Main Responsibilities:

    • Serve as the primary contact for local regulatory authorities and as a Pharmacovigilance expert according to local requirements.
    • Maintain prompt and effective communication with local regulatory authorities.
    • Provide local regulatory intelligence screening and expert advice.
    • Collect and report locally suspected Adverse Drug Reactions (ADRs) or Individual Case Safety Reports (ICSRs).
    • Oversee local risk minimization measures related to urgent safety restrictions and emerging safety issues.
    • Review and provide linguistic input on local Product Information and mock-ups.
    • Conduct local non-indexed literature screening and monitor regulatory authority websites for potential ADRs and safety information.
    • Support audits and inspections.
    • Handle local Quality Assurance tasks, including suspected falsified products and quality alerts from health authorities.

    Qualifications

    • Bachelor’s Degree in Life Sciences, Chemistry, Nursing, or equivalent experience.
    • Demonstrated experience in the pharmaceutical or CRO industry or a regulatory body.
    • Experience in LCPPV/LCPRA roles is essential.
    • PV training and/or relevant working experience, with a solid educational background as required locally.
    • Expert knowledge of ICH GVP and relevant local legislation.
    • Proficiency in English (written and verbal) and the local language.
    • Proficiency in MS Office applications, including Word, Excel, and PowerPoint.
    • Must be set up to work as a freelancer/consultant.

    Additional Information

    Why PrimeVigilance?

    We are committed to diversity, equity, and inclusion, creating an equal-opportunity workplace where individuals from all backgrounds can thrive. Our human-centric approach emphasizes collaboration, recognizing that our people are our greatest strength.

    Our Core Values:

    • Quality
    • Integrity & Trust
    • Drive & Passion
    • Agility & Responsiveness
    • Belonging
    • Collaborative Partnerships

    If our values resonate with you, PrimeVigilance could be the perfect fit! We look forward to welcoming your application.

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