Vendor Management Mgr

Job Overview:

Pay Range: $58.82hr - $63.82hr

Requirement/Must Have:

• Previous pharmaceutical industry experience in contract or alliance management preferred.
• A Bachelor's Degree in medical or life science area with a minimum of 8 years' relevant PV experience required; or a healthcare professional (HCP e.g. RN or R.Ph) with a minimum of 5 years' experience, including 3 years in safety reporting.
• Intermediate proficiency in Windows, MS Word, PowerPoint and Excel required.
• Maintains up to date knowledge of the regulations and guidelines issued by FDA and ICH.

Responsibilities:

• Ensure oversight and management of all contract and vendor related activities pertaining to Patient Safety including contract review and vendor management support in regard to safety information reporting.
• Serve as a liaison between internal departments on Pharmacovigilance Agreement (PVA) related matters.
• Contribute 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.
• Manage responsibilities and maintain oversight toward Patient Support Programs (PSP), Market Research Programs (MRP), call centers, digital health initiatives, social/digital media monitoring services, and Registries.
• Oversee safety information reconciliation and QC activities from suppliers and corporate partners to ensure compliance with PVA requirements.
• Support development and maintenance of Pharmacovigilance System Master File (PSMF).
• Ensure accuracy and completeness of data collection programs and associated PVAs in the Global Patient Safety PV Oversight System.
• Monitor and manage the Patient Safety Contracts Management mailbox.
• Collaborate with internal units and global partners to ensure late reports from suppliers and business partners have been correctly identified, documented, and reported.
• Perform proper root cause analysis, identification, documentation, correction, and corrective and preventive action as appropriate.
• Support internal and external training activities related to contract and vendor management.
• Provide guidance to contract owners and other stakeholders on safety reporting requirements and PVAs.
• Provide strategic input and contribute to process and quality improvement initiatives.
• Ensure compliance with all Federal regulations, guidance, and company SOPs regarding safety information reporting from post-marketing sources and clinical trials complaint handling.
• Liaise with suppliers and corporate partners on safety reporting and monitoring issues.

Nice to Have:

• Advanced degree preferred.

Skills:

• Pharmacovigilance Agreement (PVA).
• Vendor Management.
• Contract Review.
• Safety Information Reporting.
• Project Management.
• Root Cause Analysis.
• Regulatory Compliance.
• FDA Guidelines.
• ICH Guidelines.
• MS Office Suite.
• Alliance Management.

Qualification And Education:

• Excellent organizational skills with high attention to detail.
• Excellent project management skills, with ability to manage multiple priorities and move projects forward while maintaining high quality and meeting deadlines.
• Strong verbal and written communication skills.
• Excellent communication and presentation skills.