Bristol-Myers Squibb Company

Associate Director External Affairs

Princeton, NJ, US
Sep 07, 2018
Required Education
Bachelors Degree
Position Type
Full time
Wallingford Transition

PVA Associate Director, External Affairs (EA)
R&D - Global Pharmacovigilance & Epidemiology (GPV&E), External Affairs (EA)

Purpose/Objective of the job:
Participates and/or facilitates multi-functional teams in the timely development of high quality Pharmacovigilance Agreements (PVAs) to support BMS License Contracts and Clinical Studies.

Key Responsibilities and Major Duties:
• Has a general understanding, and stays abreast of, current and evolving Regulatory guidelines related to safety reporting for worldwide business regions, and actively applies such learnings to PVA-related activities
• Reviews and negotiates complex language in license contracts, manages sensitive and confidential information, and advises GPV&E colleagues on impact of changing regulations and other external influences on safety data contractual obligations
• Builds and maintains strong relationships with other BMS functional areas and license partner representatives to complete and facilitate implementation of PVAs and ensure compliance with pharmacovigilance requirements
• Serves as a liaison between GPV&E headquarters and international BMS business offices (e.g. PV affiliates) to support development of PVAs and pharmacovigilance activities
• Participates in the coordination and maintenance of licensing data collection and tracking systems for business agreements and PVAs, verifying PVA responsibilities with appropriate colleagues in GPV&E
• Manages PVA documentation including but not limited to active & terminated agreements as well as PVA implementation notifications. Responsible for initiating PVA implementation checklists.
• Manages storage and maintenance of PVAs and PVA templates
• Identifies ways to improve productivity and quality standards for PVA-related deliverables and actively participates in efforts to remedy non-compliance situations
• Provides support for development of process flows and work practices to clarify PVA-related systems and procedures to ensure compliance with pharmacovigilance requirements
• Conducts thorough and accurate analysis of data, gathers critical information, effectively assesses (with manager) required team resources, and delivers quality solutions to critical business tasks
• Works with QST to provide support and guidance on PVA related audit/inspection issues. Provides subject matter expertise in related activities. Provides response on relevant CAPAs.

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)
Supervisory Responsibility (List job titles of positions that report directly or indirectly to this position and indicate nature of relationship)

The following positions would not necessarily report to but work with, shadow, and collaborate with the PVA Associate Director: PVA Manager, PVA Associate

Key Stakeholders/Contacts - describe this position's key internal matrix relationships and key external stakeholders/clients

Works with Business Development, Legal, Regulatory, and GPV&E functional areas and serves as a liaison between GPV&E headquarters and international BMS business to support the development of PVAs and associated pharmacovigilance activities
with external business partners

List of minimum requirements
• Degree/Certification/Licensure Minimum B.S. Degree (equivalent, advanced degree or MBA preferred) in a relevant scientific field, such as pharmacy, nursing, or other life sciences
• Experience - Responsibility and minimum number of years At least 5-10 years of relevant experience in regulatory, safety, licensing, or clinical research function with a pharmaceutical company
• Ability to participate and/or lead multifunctional teams and act as representative in meetings between BMS and licensing partners
• Demonstrated ability to read and understand complex language in legal contracts, manage sensitive and confidential information, and analyze complex problems/data
• Experience gathering, interpreting, and applying existing and emerging regulatory guidelines with implications for Regulatory approval and drug safety reporting
• Demonstrated ability to work with a range of technically and culturally diverse people to meet high quality requirements within tight timelines
• Strong organizational skills, ability to handle multiple projects, and effectively communicate to diverse audiences at multiple levels within the company and through various formats (i.e., presentations, written proposals/ reports/correspondence).
• Competencies - knowledge, skills, abilities, other Good working knowledge of the drug development process, regulatory guidelines (e.g. FDA, ICH, etc.) relating to pharmacovigilance, and Good Clinical Practices
• Software that must be used independently and without assistance (e.g., Microsoft Suite) Microsoft suite, SharePoint, applications as required by department/position
Familiarity with web-based systems (LEAD, E-time)
• Travel Required (nature and frequency) Occasional travel for meetings
• Overnight Absences Required (per typical month) Rarely
• Describe exposure to any hazards/disagreeable conditions in the work environment None