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

    Primevigilance
    2+ years
    Not Disclosed
    Remote - Europe
    10 Nov. 19, 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

    Job Title: Freelance Local Contact Person - Pharmacovigilance & Regulatory Affairs at PrimeVigilance

    Company Description: PrimeVigilance, part of Ergomed Group, is a global leader in pharmacovigilance, offering expert services across Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. Established in 2008, we provide high-quality support to pharmaceutical and biotechnology partners of all sizes, maintaining strong relationships in various therapy areas, including medical devices. With a dedicated workforce across Europe, North America, and Asia, we are committed to delivering first-class services to our clients.

    Job Description: PrimeVigilance is looking for a talented freelancer/consultant to join our team as the Local Contact Person for Pharmacovigilance and Regulatory Affairs (0.5 FTE). In this role, you will have the opportunity to enhance your expertise within the pharmacovigilance and regulatory affairs field, working within an international team.

    Main Responsibilities:

    • Serve as the primary contact for local regulatory authorities and pharmacovigilance expert as per local requirements.
    • Communicate promptly and effectively with local regulatory authorities.
    • Provide local regulatory intelligence screening and expert advice.
    • Collect and report locally suspected ADRs or ICSRs (FUs, translations).
    • Manage and oversee risk minimization measures related to safety restrictions and emerging safety issues.
    • Review and provide linguistic input on local Product Information and mock-ups.
    • Perform local non-indexed literature screening and screening of regulatory authority websites for potential ADRs and safety information.
    • Support audits and inspections.
    • Handle local QA tasks, such as suspected falsified products, quality alerts received from health authorities, and other quality-related requirements from the local market.

    Qualifications:

    • Bachelor's Degree in Life Sciences, Chemistry, Nursing, or equivalent experience.
    • Experience in pharmaceutical or CRO industry, or regulatory bodies.
    • Must have experience in LCPPV/LCPRA roles.
    • PV training and/or working experience and other educational qualifications as required locally.
    • Expert knowledge of ICH GVP and local regulatory requirements.
    • Proficiency in English (both written and verbal) and local language.
    • Proficiency in MS-Office applications, including Word, Excel, and PowerPoint.
    • Must currently be set up to work as a freelancer/consultant.

    Why Join PrimeVigilance? At PrimeVigilance, we prioritize diversity, equity, and inclusion, creating a workplace where individuals from all backgrounds can thrive. Our core values—Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, and Collaborative Partnerships—guide everything we do. If these values resonate with you, PrimeVigilance could be the perfect company for you.

    We look forward to receiving your application and welcoming you to our team!

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