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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, USA
    10 Nov. 25, 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

    Company Description:
    We are PrimeVigilance, part of the Ergomed Group, a specialized mid-sized pharmacovigilance service provider established in 2008. With staff based across Europe, North America, and Asia, we provide world-class services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

    PrimeVigilance has grown organically year after year, supporting pharmaceutical and biotechnology partners of all sizes, and becoming a global leader in its field. We work across all therapy areas, including medical devices.

    Job Description:
    We are excited to offer a unique opportunity for a freelancer/consultant to join our team as the Local Contact Person for Pharmacovigilance and Regulatory Affairs at 0.5 FTE. This role allows you to work in a dynamic, international team and deepen your expertise in pharmacovigilance (PV) and regulatory affairs.

    Main Responsibilities:

    • Serve as the primary contact for local regulatory authorities and pharmacovigilance expert in accordance with local requirements.
    • Maintain prompt and effective communication with local regulatory authorities.
    • Provide expert advice on local regulatory intelligence and screening.
    • Collect and report locally suspected ADRs or ICSRs (including follow-ups and translations).
    • Oversee and manage local risk minimization measures, especially related to urgent 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 monitor regulatory authority websites for potential Adverse Drug Reactions (ADRs) and safety information.
    • Support audits and inspections.
    • Handle local quality assurance (QA) tasks, such as suspected falsified products, quality alerts from health authorities, and other market-related quality requirements.

    Qualifications:

    • Bachelor’s degree in Life Sciences, Chemistry, Nursing, or an equivalent field.
    • Proven experience within the pharmaceutical, CRO, or regulatory body industries.
    • Experience in LCPPV and LCPRA roles.
    • PV training and/or relevant work experience is essential.
    • Expert knowledge of ICH GVP and local regulations relevant to your territory.
    • Fluency in English (written and spoken) and proficiency in the local language.
    • Proficient in MS Office, including Word, Excel, and PowerPoint.
    • Must be set up to work as a freelancer/consultant.

    Additional Information:
    At PrimeVigilance, we foster a culture of diversity, equity, and inclusion, where individuals of all backgrounds, genders, and cultures can contribute and grow. Our people-first approach is at the heart of everything we do, and it’s our greatest strength in improving patient lives globally.

    We offer:

    • A collaborative work environment with an international team.
    • Opportunities for professional growth and development.
    • A chance to work with world-class pharmaceutical and biotech partners.

    If our values resonate with you, PrimeVigilance could be the perfect place for you to contribute to improving patient safety. We look forward to welcoming your application!

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