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    Manager, Pv Partner Management, Clinical Safety & Pharmacovigilance (Cspv)

    Hire Talent
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 5, 2024
    Job Description
    Job Type: Full Time Remote 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 Title: Manager, PV Partner Management, Clinical Safety & Pharmacovigilance (CSPV)
    Location/Schedule: Local preferred with onsite flexibility (1x per week); 100% remote possible
    Company: [Company Name]

    Job Overview

    The Manager, PV Partner Management, Clinical Safety & Pharmacovigilance (CSPV) will be responsible for managing PV regulatory intelligence, maintaining and supporting the impact assessment of emerging global regulatory requirements, and overseeing safety information reporting for DSI products. This role will also be key in managing Pharmacovigilance Agreements (PVAs), Safety Data Exchange Agreements (SDEAs), and vendor partnerships. The manager will work closely with service providers, CROs, and internal stakeholders to ensure accurate safety reporting for both investigational and marketed products while ensuring compliance with global safety regulations.

    Key Responsibilities

    • PV Regulatory Intelligence & Compliance:

      • Oversee the dissemination, maintenance, and assessment of global regulatory requirements through collaborations with vendors, CROs, and other regulatory sources.
      • Ensure that emerging regulatory requirements are understood and incorporated into the company’s safety processes.

    • Vendor & Partner Management:

      • Manage contractual arrangements including Pharmacovigilance Agreements (PVAs), Safety Data Exchange Agreements (SDEAs), and vendor outsourcing agreements.
      • Coordinate with external service providers (e.g., Call Centers, case processing vendors) to ensure timely and accurate adverse event reporting.
      • Build and maintain strong relationships with contract partners to ensure compliance with good pharmacovigilance practice (GVP).

    • Subject Matter Expertise & Compliance Guidance:

      • Provide technical guidance on the implementation of corrective and preventive actions (CAPA) to address non-conformance issues across internal teams, contract partners, and CROs.
      • Offer subject matter expertise regarding the regulatory requirements for investigational and marketed products.

    • Cross-Functional Collaboration:

      • Communicate effectively across teams and regions to ensure safety data is assessed, reported, and managed in line with regulatory expectations.
      • Collaborate with cross-functional teams to ensure the prioritization and successful execution of key safety and regulatory initiatives.

    Qualifications

    Education & Experience:

    • Bachelor’s degree in life sciences or related field.
    • Minimum of 5+ years of experience in Pharmacovigilance operations, regulatory intelligence, and/or PV agreements.
    • Strong experience with FDA regulations and global PV regulations.
    • Expertise in managing CROs, Call Centers, and case processing vendors.

    Skills & Competencies:

    • In-depth knowledge of PV agreements, including Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs).
    • Solid understanding of clinical safety and pharmacovigilance systems (e.g., clinical and safety databases).
    • Strong project management skills with the ability to manage shifting priorities.
    • Excellent written and verbal communication skills, with the ability to collaborate effectively across functions and regions.

    Additional Information

    • Remote Eligible: Local candidates preferred with the ability to come onsite once per week. A fully remote option may be available.
    • Technology Requirements: Candidates must have their own laptop/desktop to perform the work.

    Equal Opportunity Employer

    We are committed to providing an inclusive and diverse work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, sexual orientation, gender identity, or any other characteristic protected by applicable law.

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