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    Pv Associate/Sr Pv Associate

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    0-2 years
    Not Disclosed
    Remote
    10 Oct. 22, 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

    Pharmacovigilance Associate - Chennai, India

    About Us: ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment that drives innovation and excellence. Join us on our mission to shape the future of clinical development.

    Position Overview: We are currently seeking a Pharmacovigilance Associate to join our diverse and dynamic team.

    What You Will Be Doing:

    • Review and process safety events (pre-marketing, post-marketing, medical device, and drug) per assigned tasks and project-specific procedures.
    • Perform reviews of abstracts and full articles to identify safety information for both pre- and post-marketed products.
    • Generate data listings from the safety database and ensure data accuracy.
    • Complete adverse event follow-up in writing and/or by phone based on client requirements.
    • Provide input and review safety tracking systems for accuracy and assist in maintaining project files.
    • Perform safety reviews of clinical and diagnostic data as part of case processing.
    • Develop the Safety Management Plan and specific processes for project consistency.
    • Support post-marketing safety activities, including PSMF, RMP, and PBRER.
    • Liaise with investigational sites, reporters, and sponsors regarding safety issues.
    • Collaborate with ICON Medical Monitors, project managers, and other departments as needed.
    • Assist in identifying out-of-scope activities with the Pharmacovigilance Project lead.
    • Attend project team and sponsor meetings, presenting safety processes at kick-off and investigator meetings.
    • Generate Aggregated Safety Reports (e.g., Development Safety Update Reports, IND Annual Reports) through data retrieval and other assigned tasks.
    • Support interim data analysis for DMC reviews.
    • Maintain the safety database and ensure data quality following established processes.
    • Assist in SAE/AE reconciliation and support signal detection and risk management activities.
    • Propose solutions for procedural and technical issues.
    • Support audits and inspections as required.

    Your Profile:

    • Experience in a Pharmaceutical/CRO environment.
    • At least 1 year of experience in pharmacovigilance.
    • Excellent verbal and written communication skills.
    • Detail-oriented with strong organizational and time management skills.
    • Ability to work effectively both independently and as part of a global team.

    What ICON Can Offer You: Our success depends on the quality of our people. That’s why we prioritize building a diverse culture that rewards high performance and nurtures talent.

    Benefits include:

    • Various annual leave entitlements.
    • A range of health insurance offerings.
    • Competitive retirement planning.
    • Global Employee Assistance Programme, LifeWorks, providing 24-hour support for you and your family.
    • Life assurance and flexible country-specific optional benefits.

    Commitment to Diversity: ICON is an equal opportunity and inclusive employer, committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

    Application Process: If you need a reasonable accommodation due to a medical condition or disability during the application process or to perform essential functions of the position, please let us know.

    Interested but unsure? We encourage you to apply regardless of whether you meet all requirements. You might be exactly what we’re looking for.

    Current ICON Employees: Please click here to apply.

     

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