Sr. Manager, PV Compliance and Vendor Quality

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Sr. Manager, PV Compliance and Vendor Quality (Ref: 4360), Bristol-Myers Squibb Company, Princeton, NJ. Provide quality oversight through ongoing monitoring of Global Pharmacovigilance with a focus on quality related aspects of the safety by drawing on experience with IT project management such as maintenance of JIRA with compliance database vendor, HP ALM (HP Application Lifecycle Management) for testing and approving the business requirements; SAAS software development; Share Point management; Spotfire; and global pharmacovigilance (GPV) regulatory requirements, Argus or Arisg patient safety database. Develop, implement and coordinate quality and compliance monitoring activities with respect to Individual Case Safety Reports (ICSRs), and other relevant areas of pharmacovigilance in support of a strong GPV Quality Management System. Collaborate with Global Safety Operations, International, Global Risk Management, and Medical Review Teams for continuous quality improvement by ongoing communications regarding any quality trends and reinforcement of process. Evaluate and revise quality monitoring strategies and programs based on results, business risk, external and/or internal feedback. Ensure effective communication to WWPS (Worldwide Patient Safety) stakeholders regarding the identified risks and recommendations for the potential improvement of quality. Contribute to the development of departmental standard operating procedures and training relating to core responsibilities. Maintain an in-depth knowledge of global pharmacovigilance regulations that impact the research, development and marketing of medicines and devices as well as relevant the company policies and procedures within the area of expertise. Manage and oversee the measure of effectiveness of health authority, audit or deviation CAPA implementation to ensure improvement and fulfillment of BMS’ agency obligations. Maintain quality monitoring and oversight programs and ensure ongoing vendor management for key pharmacovigilance vendors. Ensure effective communication with key WWPS stakeholders and vendors to include review of their performance metrics ensuring the expectations are met and that delegated functions are performed in accordance with contractual and regulatory requirements. Escalate any suspected compliance, quality concerns or potential risks associated with in house or outsourced Pharmacovigilance activities. Plan remediation actions in collaboration with respective stakeholders where vendor performance or compliance expectations fail to meet minimum thresholds. Provide support to the WWPS organization for the purpose of maintaining a standard of quality and compliance with existing global regulations, compliance requirements and internal policies and procedures. Partner with management of PV Compliance and Risk Management organization to identify opportunities for process improvement to increase the effectiveness and efficiency of the WWPS organization.

40 hrs/week, Mon-Fri, 8:30 a.m. - 5:30 p.m. 

MINIMUM REQUIREMENTS:

Bachelor’s degree or foreign equivalent degree in Health Administration, Pharmacology, Life Science or a related field, plus five (5) years of post-baccalaureate experience in pharmaceutical industry.

Must have three (3) years of experience in pharmacovigilance, drug development, clinical development or regulatory affairs with knowledge of IT business process and business analysis.

Must have experience with:

• IT project management such as maintenance of JIRA with compliance database vendor, HP ALM (HP Application Lifecycle Management) for testing and approving the business requirements;
• SAAS software development;
• Share Point management;
• Spotfir