PVA Manager, External Affairs
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.
The PVA Manager, External Affairs, 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 key international 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 and verifying PVA responsibilities with appropriate colleagues in GPV&E
- 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/allocates required team resources, and delivers quality solutions to critical business tasks
- Works with manager to evaluate resource needs, train skilled workers, and manage daily activities of assigned External Affairs resources. Provides developmental opportunities for self and team
- Degree/Certification/Licensure Minimum B.S. Degree ( or equivalent) in a relevant scientific field, such as pharmacy, nursing, or other life sciences.
- Experience - Responsibility and minimum number of years At least 3-5 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)