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    Sr Specialist Pv Agreements, Vendor Management

    Organon
    3+ years
    Not Disclosed
    Mumbai
    10 Nov. 24, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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: Pharmacovigilance (PV) Agreements Lead

    Position Overview

    Location: Remote/Onsite options available
    Job Type: Regular
    Travel Requirements: Must meet all applicable travel and credentialing requirements, including vaccination prerequisites.
    Relocation: Not provided.
    Reports To: Pharmacovigilance and Alliance Management Team

    The PV Agreements Lead is the primary point of contact for pharmacovigilance agreements (PVA) associated with vendors and business partners. This role ensures compliance with company policies and health authority regulations and provides mentorship and guidance to local pharmacovigilance responsible leads. The PV Agreements Lead acts as a Subject Matter Expert (SME) for audits, inspections, quality initiatives, and corporate activities.

    Key Responsibilities

    1. PV Agreement Management

      • Draft and incorporate appropriate safety reporting language into various agreements, including Master Service Agreements (MSAs), Statements of Work (SOWs), Purchase Orders (POs), and business partner agreements.
      • Ensure clear accountability and responsibility between the company and business partners through precise PV language in agreements.

    2. Due Diligence and Compliance

      • Conduct PV due diligence for U.S. and global contracts to ensure adherence to corporate policy and regulatory standards.
      • Collaborate with procurement and project owners to embed appropriate PV classifications and requirements in agreements.

    3. Mentorship and Guidance

      • Provide mentorship and guidance to local PV affiliates regarding vendor PV agreements.
      • Share expertise and best practices related to PV agreements across the organization.

    4. Audit and Inspection Readiness

      • Support inspection readiness and Pharmacovigilance System Master File (PSMF) preparation.
      • Act as a PV SME for audits, inspections, and quality incidents.

    5. Collaboration and Stakeholder Engagement

      • Work closely with procurement, vendors, business partners, and internal stakeholders to manage PV obligations.
      • Maintain strong relationships with regional and global teams to ensure alignment on PV activities.

    6. Quality and Process Improvement

      • Support quality initiatives related to PV agreements and propose process improvements.
      • Review and monitor vendor performance to ensure adherence to PV-related responsibilities.

    Required Education, Experience, and Skills

    Education:

    • Bachelor’s or Master’s degree in life sciences, healthcare, or pharmaceutical-related fields.

    Experience:

    • Minimum of 3 years in the pharmaceutical industry focusing on pharmacovigilance-related activities.
    • Demonstrated experience collaborating with vendors and business partners.
    • Knowledge of procurement processes and third-party engagements.

    Skills:

    • Proficiency in developing and managing PV agreements for vendors and business partners.
    • Strong understanding of PV regulations, principles, and systems.
    • Analytical mindset with attention to detail and a quality focus.
    • Effective problem-solving, conflict resolution, and project management abilities.
    • Proficient in Office 365 applications and Veeva Vault.

    Key Competencies:

    • Clear differentiation between vendor and business partner responsibilities.
    • Strong interpersonal skills with the ability to build close stakeholder relationships.
    • Autonomy in managing competing priorities and adapting to changing business needs.

    Preferred Qualifications

    • Hands-on experience in drafting PV agreements for diverse business scenarios, including marketing and commercial programs.
    • Familiarity with global pharmacovigilance requirements and systems.

    About Organon

    Organon is a global healthcare company dedicated to improving lives through innovative health solutions, with a strong focus on women’s health. Our mission is to expand access to health products and provide trusted solutions for diverse needs worldwide.

    Employment Notes

    • Diversity Commitment: Organon embraces inclusivity and is an equal opportunity employer.
    • Search Firm Policy: Organon does not accept unsolicited referrals from search firms without prior written agreements.

    For more information on Equal Employment Opportunity rights, please review:

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