Biovail Corporation (TSX, NYSE: BVF) with its corporate headquarters in Mississauga, Ontario is one of the world's leading specialty pharmaceutical companies. With revenues of US$1.07 billion in 2006, the Company is engaged in the formulation, clinical testing, registration, manufacture and commercialization of pharmaceutical products, utilizing advanced drug-delivery technologies, both directly and through partners. Biovail operates wholly owned subsidiaries in Barbados, Canada, the United States, Ireland and Puerto Rico.
POSITION SUMMARY
The main role of the Associate, Regulatory Affairs is to supervise post-market pharmacovigilance (PV) submissions and records in accordance with Health Canada requirements.
KEY RESPONSIBILITIES
Performs timely pharmacovigilance reporting and tracking. Maintains thorough records in compliance with regulatory requirements. Interfaces with Medical Information, licensees, and contract providers as required for complete PV information.
Assists in preparation of regulatory submissions to TPD (NDS, SNDS, NCs, CTAs, Annual Notifications, CPPs).
Liaises with other departments and divisions, Health Canada, license partners and service providers as required.
Participates in review of RA submissions prior to filing.
Participates in Change Control, Product Label, and Promotional Material reviews.
REQUIREMENTS
A University degree, preferably in Business or Sciences.
Minimum of two years Pharmacovigilance reporting and Regulatory experience in a pharmaceutical environment.
Knowledge of GMP, GCP, GLP and ICH regulations.
Excellent attention to detail.
Strong written and verbal communication skills.
Good interpersonal and negotiation skills.
Excellent time management skills.
Computer literate in a Windows-based environment.
Biovail Corporation is an equal opportunity employer. We wish to thank all applicants in advance for their interest; however, only those who will be considered for an interview will be contacted.