Bristol-Myers Squibb Company

Pharmacovigilance Business Partner Compliance Manager

Location
Princeton, NJ, US
Posted
Dec 01, 2018
Ref
R1510856
Required Education
Associate Degree
Position Type
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Key Responsibilities and Major Duties:
  • Manage the Individual Case Safety Reports (ICSR) compliance process with BMS GPV&E's global business partners, including exchange of corrective and preventive actions (CAPA) for late ICSR submissions to health authorities.
  • Manage compliance with ICSRs exchanged outside Pharmacovigilance Agreement (PVA) specified timeframes; host joint company quality and compliance meetings as needed.
  • Represent the compliance team during Business Partner Audits and pharmacovigilance Inspections
  • Manage quality activities related to implementation and monitoring of Pharmacovigilance Agreements (PVAs) with BMS GPV&E's global business partners.
  • Review draft PVAs for sections relating to Quality and compliance and inspection/audit related activities and represent Quality in the PVA Implementation meetings in order to assess impact of new or revised PVA expectations
  • Maintain close partnership with Quality and compliance team for all matters relating to compliance to ensure alignment with Global Compliance Metric process
  • Maintain PV compliance and quality oversight of partnerships during asset acquisition and transition
  • Collaborate with other Quality and Inspection Readiness Team members for business partner related activities including: changes to the safety database, audit and inspections.
  • Liaise with Global Quality and the Inspection Readiness team to share intelligence of PVA compliance in order provide input for potential BMS audits of partners
  • Liaise with Adverse Event processing team to share intelligence of PVA compliance in order to determine impact to ICSR processing and other key business operations
  • Collaborates with all functional areas within GPV&E and R&D to enable oversight of the performance of pharmacovigilance business partners by communicating issues, and facilitates process improvement or other activities needed to mitigate risk associate with external relationships. Key stakeholders include the External Affairs, Adverse Event Processing, Signal Management, Safety Scientists and Analytics, and Submissions.


Required:
  • BS/BA degree required
  • Strong preference of 5 or more years in pharmacovigilance, drug development, clinical development, quality, regulatory, or equivalent.
  • Experience interacting and building effective relationships with senior management, interdepartmental stakeholders and business partners.
  • Demonstrated ability to affect organizational change and to get results supporting company objectives under complex conditions.
  • Demonstrated ability to work and manage effectively in a team environment within a matrix organization as project team leader.


Ideal Candidates Would Also Have:
  • Knowledge of worldwide regulations pertaining to pharmacovigilance
  • Experience in the concepts of quality management system, self-identified quality issues, root cause analysis, corrective, and preventive actions
  • Knowledge of Individual Case Safety Reports (ICSRs) processing
  • Successful and creative negotiation of difficult issues.
  • Possesses excellent communication skills which are used to convey recommendations for process improvements and enhancements to our internal and external customers.