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    Senior Drug Safety Associate

    Eversana
    5+ years
    Not Disclosed
    Pune
    10 Nov. 27, 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 Opportunity: Pharmacovigilance (PV) Associate at EVERSANA 🚀

    At EVERSANA, we are proud to be certified as a Great Place to Work globally. Our mission is to create a healthier world, and we are looking for talented individuals to help us deliver next-generation commercialization services to the life sciences industry. With over 7,000 employees, we serve more than 650 clients, from innovative biotech start-ups to established pharmaceutical companies. Together, we are making an impact every day.

    Position: Pharmacovigilance (PV) Associate
    Location: [Remote / Office-based]
    Experience: 5+ years in drug safety, including 3 years in pharmacovigilance

    Job Description

    THE POSITION:
    As a Pharmacovigilance (PV) Associate, you will support the client PV department in processing and analyzing safety data from clinical trials and post-marketing reports.

    Essential Duties and Responsibilities:

    • Collaborate with PV Management and Project Managers to meet client deadlines.
    • Assist PV team members in managing workload and ensuring timely reporting to regulatory authorities.
    • Participate in the development of documents such as aggregate reports, SOPs, and work instructions.
    • Process adverse event (AE) reports, track case status, and promote accurate reporting.
    • Assess reportability of AEs and apply clinical judgment when needed.
    • Code AEs in MedDRA and use clinical judgment to link medications to WHODRUG.
    • Perform quality control to ensure accuracy in safety database and regulatory reporting forms.
    • Create narrative drafts and follow up on queries regarding reported events.
    • Lead a team of Drug Safety Coordinators and Associates to streamline case processing.
    • Conduct regular reconciliations of SAEs between safety and clinical trial databases.

    Minimum Knowledge, Skills, and Abilities:

    • BS degree in a life science discipline (e.g., pharmacy, nursing) preferred.
    • 5 years of experience, including 3 years in drug safety.
    • Knowledge of MedDRA and WHODRUG coding.
    • Familiarity with FDA and international adverse event reporting regulations (ICH).
    • Strong attention to detail, teamwork, and initiative.
    • Excellent communication skills and the ability to work independently.

    Why EVERSANA?

    • Join a team committed to improving patient lives around the world.
    • Work in a diverse, inclusive culture where everyone’s perspectives matter.
    • We offer professional growth opportunities, and we prioritize workplace equity.

    EVERSANA is committed to diversity and inclusion, welcoming candidates from all backgrounds, experiences, and perspectives.

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