Patient Safety Vendor Manager

Artech L.L.C.; Plainsboro Township (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Artech L.L.C. seeks a senior Patient Safety Vendor Management professional to oversee contract reviews, vendor management, and PVA compliance. You will liaise with USO Patient Safety, QA, Legal, and external partners to ensure safety reporting data integrity and regulatory alignment.

Responsibilities include managing PVAs, supporting PSFM and related systems, and driving process improvements while training staff on safety reporting requirements.

Qualifications

• A Bachelor’s Degree in medical or life science with 8+ years PV experience; or an HCP with 5+ years including 3 in safety reporting.
• Advanced degree is preferred.
• Strong organizational, project management and communication skills.
• Proficient in Windows, MS Word/Excel/PowerPoint; knowledge of FDA requirements and GMP.
• Experience in contract or alliance management is preferred.

Responsibilities

• Oversee Patient Safety Vendor Management responsibilities and contract reviews.
• Manage PVA requirements and supplier relations; ensure compliance.
• Monitor safety information reconciliation and QC with suppliers.
• Support development and maintenance of PV System Master File (PSMF).
• Coordinate training and provide guidance on safety reporting requirements.
• Collaborate across Patient Safety and global teams; ensure audit readiness and SOP updates.

Skills

Pharmacovigilance knowledge

Project management

Safety reporting

Contract/vendor management

Regulatory compliance

FDA/GMP regulations

Communication skills

MS Office (Word, PowerPoint, Excel)

Education

Bachelor's degree in medical or life sciences

Advanced degree preferred

Tools

Windows

MS Office

Job description

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 in regard to safety information reporting. To serves as a liaison between USO PS & GxP BUSINESS OPS, USO Patient Safety Group and other departments on Pharmacovigilance Agreement (PVA) related matters. To 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

Relationships:

This position reports to the Associate Director or Director, Patient Safety Vendor Management. This position works closely with including, but not limited to the following: all units in Patient Safety, USO QA, Legal, Compliance, Commercial, Finance, Global Business Services Bangalore (GBS-BLR), PV & GDP Auditor(s) as well as with counterparts in Global Patient Safety and Contract Owners. External relationships include interactions with Client’s business partners, suppliers, healthcare professionals and with FDA 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 the unit’s functional and corporate goals.
• Manages Patient Safety Vendor Management’s responsibilities and maintains oversight toward Patient Support Programs services, and Registries incl. 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 Pharmacovigilance System Master File (PSMF). 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. Assigns and delegates tasks as appropriate.
• Understands Patient Safety case processing and CLIENT contracting operations including tool and systems used, exceptions processes, and workflows.
• Collaborates with all units within Patient Safety, other business areas at CLIENT, GBS-BLR and Global Patient Safety to ensure late reports from suppliers and business partners have been correctly identified and documented as per relevant SOPs, and reported to management. Perform proper root cause analysis, identification, documentation, correction, corrective and preventive action, as appropriate.
• Supports internal and external training activities related to contract and vendor management.
• Provides guidance to contract owners and other stakeholders on safety reporting requirements, incl. PVAs.
• Contributes to business continuity and resource plaClientng. Ensures adequate coverage for essential tasks at all times.
• Provides strategic input and contributes to process / quality improvement initiatives.
• Guides the successful completion of major programs or initiatives, and may function in a project leadership role.
• Participates in onboarding and training of new Patient Safety Vendor Management staff and contingency workers

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 FDA and ICH
• Liaises with suppliers and corporate partners on safety reporting and monitoring issues as appropriate.
• Serves as primary contact, facilitator and communicator of information to other departments within CLIENT and CLIENTS concerning contracts, vendors and PVA requirements related matters.

QUALIFICATIONS:

• 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. Advanced degree preferred.
• 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
• Excellent oral and written communication skills.
• Intermediate proficiency in Windows, MS Word, PowerPoint and Excel required
• Knowledge of FDA requirements in safety information reporting and GMP regulations.
• Previous pharmaceutical industry experience in contract or alliance management preferred.