Senior Pharmacovigilance Vendor Management Manager

Pay Range: $58.82hr - $63.82hr

Job Overview:

The Senior Patient Safety Vendor Management Manager ensures oversight and management of all contract and vendor-related activities pertaining to Patient Safety, including contract review and vendor management support regarding safety information reporting. This role serves as a liaison between business operations, patient safety, and other departments on Pharmacovigilance Agreement (PVA) matters, and supports quality monitoring activities to ensure partner compliance with PVA requirements.

Purpose:

To ensure oversight and management of all contract and vendor-related activities pertaining to Patient Safety including, but not limited to, contract review and vendor management support regarding safety information reporting.

To serve as a liaison between Business Operations, Patient Safety, and other departments on Pharmacovigilance Agreement (PVA) related matters.

To contribute to and support quality monitoring activities related to safety information reporting and quality tasks performed by suppliers and business partners to ensure compliance with PVA requirements.

Relationships:

This position reports to the Associate Director or Director of Patient Safety Vendor Management.

This position works closely with all units in Patient Safety, Quality Assurance, Legal, Compliance, Commercial, Finance, Global Business Services, and PV & GDP Auditors, as well as counterparts in Global Patient Safety and internal Contract Owners. External relationships include interactions with business partners, suppliers, healthcare professionals, and regulatory agency personnel concerning safety information reporting matters related to contracts and PVA requirements.

Essential Functions - Administration:

• Exercises considerable latitude and applies extensive pharmacovigilance knowledge and technical expertise in determining and implementing strategies consistent with functional and corporate goals.
• Manages Patient Safety Vendor Management's responsibilities and maintains oversight toward Patient Support Programs (PSP), Market Research Programs (MRP), call centers, digital health initiatives/activities, social/digital media monitoring services, and Registries, including contract review and negotiation, management of PVA requirements, and supplier relations.
• Oversees safety information reconciliation and QC activities from suppliers and corporate partners to ensure compliance with PVA requirements.
• Supports development and maintenance of the Pharmacovigilance System Master File (PSMF) and ensures accuracy and completeness of data collection programs and associated PVAs in the Global Patient Safety PV Oversight System.
• Monitors and manages the Patient Safety Contracts Management mailbox, assigning and delegating tasks as appropriate.
• Understands Patient Safety case processing and contracting operations, including tools and systems used, exception processes, and workflows.
• Collaborates with all units within Patient Safety, other business areas, global services, and Global Patient Safety to ensure late reports from suppliers and business partners are correctly identified, documented per relevant SOPs, and reported to management while performing root cause analysis, identification, documentation, correction, and preventive actions.
• Supports internal and external training activities related to contract and vendor management.
• Provides guidance to contract owners and other stakeholders on safety reporting requirements, including PVAs.
• Contributes to business continuity and resource planning, ensuring adequate coverage for essential tasks at all times.
• Provides strategic input and contributes to process and quality improvement initiatives.
• Guides the successful completion of major programs or initiatives, functioning in a project leadership role as required.
• Participates in onboarding and training of new Patient Safety Vendor Management staff and contingency workers.

Essential Functions - Regulatory Compliance:

• Ensures compliance with all Federal regulations, guidance, and company SOPs regarding safety information reporting from post-marketing sources and clinical trials complaint handling.
• Ensures local/affiliate PVA templates meet both global and local regulatory requirements.
• Provides audit and inspection readiness and support.
• Develops and maintains company pharmacovigilance SOPs.
• Maintains up-to-date knowledge of the regulations and guidelines issued by the FDA and ICH.

Business Partner Liaison:

Liaises with suppliers and corporate partners on safety reporting and monitoring issues as appropriate.

Serves as the primary contact, facilitator, and communicator of information to other internal departments concerning contracts, vendors, and PVA requirement matters.

Qualifications:

• Bachelor's degree in a medical or life science area with a minimum of 8 years of relevant pharmacovigilance experience required; or a healthcare professional (HCP, e.g., RN or R.Ph) with a minimum of 5 years of experience, including 3 years in safety reporting. An advanced degree is preferred.
• Excellent organizational skills with high attention to detail.
• Excellent project management skills, with the ability to manage multiple priorities and move projects forward while maintaining high quality and meeting deadlines.
• Strong verbal and written communication skills.
• Intermediate proficiency in Windows, MS Word, PowerPoint, and Excel.
• Knowledge of FDA requirements in safety information reporting and GMP regulations.
• Previous pharmaceutical industry experience in contract or alliance management preferred.