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    Senior Specialist, Pharmacovigilance Agreement Operations

    Organon
    2+ years
    Not Disclosed
    Mumbai
    10 Nov. 15, 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 Description

    Position: PV Agreement Specialist

    Overview:
    As a PV Agreement Specialist, you will manage and ensure the accuracy and compliance of Pharmacovigilance Agreements (PVAs) and Safety Management Plans (SMPs) in collaboration with Business Partners. You will prioritize tasks and support regulatory reporting requirements in a timely and organized manner.

    Key Responsibilities:

    • Enter PV Agreement and Safety Management Plan (SMP) data into the Veeva Business Development Lifecycle Management (BDLM) database and other related Partner systems.
    • Conduct quarterly random checks on BDLM data against source documents to verify the accuracy and update status of the information.
    • Manage and train resources and contractors to ensure consistent execution of PV Agreement activities.
    • Track, collate, and manage performance metrics from stakeholders and partners.
    • Draft initial versions of PV Agreement documents using standard templates in MS Word, and bilingual templates when needed.
    • Collaborate with PV agreement owners to finalize agreements and ensure timely submission for review and approval.
    • Maintain trackers for agreements under review and send reminders to PV agreement owners to expedite the process.
    • Assist in the annual maintenance of PV agreements, including reminders and training activities for Business Partners.
    • Collaborate with internal PV teams to maintain and update PV agreements appropriately.
    • Maintain the BDLM system, including checklists and reference guides for PV Agreement operations.
    • Ensure smooth operation and continued improvement of the BDLM system to support PV Agreement compliance.

    Required Qualifications:

    • Bachelor’s degree in a relevant field (Health Sciences, Life Sciences, or similar).
    • Minimum of 3 years of experience in Pharmacovigilance, specifically in PV Agreement and licensing management.
    • Experience with Veeva Vault or similar database management systems.
    • Strong organizational and task management skills with an ability to prioritize effectively.
    • Experience in leadership and influence in cross-functional teams.
    • Proficiency in project management and strategic planning, especially using agile methodologies.
    • Excellent communication skills for both presentation and written tasks.
    • Strong attention to detail with the ability to handle multiple priorities and deadlines.
    • Proactive, driven, and willing to contribute to team goals.
    • Strong interpersonal skills and the ability to manage stakeholder relationships.
    • Ability to adapt to changing priorities and work under pressure.
    • Fluency in English and regional languages with an understanding of cultural sensitivities.

    About Us:
    Organon is a global healthcare company dedicated to improving the lives of women and their families. With a robust portfolio, we aim to address the unmet needs of Women’s Health and expand access to biosimilars. Our mission is to make a meaningful difference in the health of communities worldwide.

    Employment Details:

    • Employee Status: Regular
    • Relocation: No relocation
    • Visa Sponsorship: Not offered
    • Travel Requirements: Must meet credentialing and vaccination requirements for applicable travel.

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