Pascale Rouben
About Pascale Rouben
Pascale Rouben is the International Pv Manager at Bristol-Myers Squibb in New Jersey, United States, responsible for EU-specific Pharmacovigilance documents and EudraVigilance registration.
Title
Pascale Rouben holds the position of International Pharmacovigilance (Pv) Manager at Bristol-Myers Squibb. Based in New Jersey, United States, this role encompasses a range of responsibilities critical to the company's pharmacovigilance functions.
Company
Pascale Rouben has been with Bristol-Myers Squibb since January 2013. Bristol-Myers Squibb is a prominent global biopharmaceutical company known for its research and development in a multiple therapeutic areas. Pascale's role involves significant contributions to the company's pharmacovigilance operations, ensuring compliance and safety across pharmacovigilance activities.
Education and Expertise
Pascale Rouben studied Design at Sint-Lukas Brussel, a reputable art and design school in Belgium. She attended the institution from 1992 to 1994, completing a two-year program. Though her education background is in design, her professional expertise has evolved significantly into pharmacovigilance, reflecting diverse skill sets and versatility in her career.
Responsibilities at Bristol-Myers Squibb
At Bristol-Myers Squibb, Pascale Rouben is responsible for the provision of EU-specific Pharmacovigilance documents for submission. This includes handling the Pharmacovigilance System Master File and its summary. She manages EudraVigilance registration for Marketing Authorization Holders (MAHs), users, and partner companies. Her role also involves interdepartmental collaboration with the European Medicines Agency (EMA) and business partners, ensuring thorough reviews of EEA CARES CCFs in relation to EMEA GFs.
Collaborations and Interdepartmental Involvement
Pascale Rouben collaborates closely with various departments within Bristol-Myers Squibb and with external stakeholders such as the European Medicines Agency (EMA). These collaborations are essential for maintaining stringent pharmacovigilance standards and ensuring compliance with regulatory requirements.