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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 a global presence spanning Europe, North America, and Asia, we provide first-class services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

    PrimeVigilance has grown organically, fostering long-lasting relationships with pharmaceutical and biotechnology partners of all sizes, and establishing ourselves as a global leader in pharmacovigilance. Our services extend across all therapy areas, including medical devices.

    Job Description:
    An exciting opportunity is available for a freelancer/consultant to join our team as the Local Contact Person for Pharmacovigilance and Regulatory Affairs at 0.5 FTE. This role offers the opportunity to work with an international team and strengthen your expertise in the broad and dynamic fields of pharmacovigilance and regulatory affairs.

    Main Responsibilities:

    • Act as the primary contact for local regulatory authorities and serve as the pharmacovigilance expert as per local requirements.
    • Ensure prompt and effective communication with local regulatory authorities.
    • Provide local regulatory intelligence screening and expert advice.
    • Collect and report locally suspected ADRs or ICSRs, including follow-ups and translations.
    • Oversee local management of risk minimization measures related to urgent safety restrictions and emerging safety issues.
    • Review and provide linguistic input for local Product Information and Mock-ups.
    • Conduct local non-indexed literature screening and review Regulatory Authority websites for potential ADRs and safety information.
    • Support audits and inspections.
    • Handle local quality assurance (QA) tasks, such as managing suspected falsified products, quality alerts from health authorities, and other quality-related market requirements.

    Qualifications:

    • Bachelor's degree in Life Sciences, Chemistry, Nursing, or a related field.
    • Demonstrated experience within the pharmaceutical, CRO, or regulatory body sectors.
    • Experience in LCPPV and LCPRA roles is essential.
    • PV training and/or relevant work experience is required.
    • In-depth knowledge of ICH GVP and local regulations for your territory.
    • Proficiency in English (both written and verbal) and the local language.
    • Proficient in MS Office applications, including Word, Excel, and PowerPoint.
    • Must be set up to work as a freelancer/consultant.

    Additional Information:
    At PrimeVigilance, we emphasize diversity, equity, and inclusion by creating an equal opportunities workplace where people of all backgrounds, genders, and cultures can contribute and grow. Our human-first approach drives our success, as our people are our greatest asset in improving patient safety.

    We offer:

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

    If our values resonate with you, PrimeVigilance may be the perfect place for you to contribute to patient safety and regulatory excellence. We look forward to receiving your application!

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