Senior Associate Pharmacovigilance

Collects, prepares and submits adverse drug reaction reports as per Canadian guidelines and PV agreements to Health Canada and cross-license companies.
Prepares draft Periodic Safety Update Reports.
Prepares risk assessments.
Collects, evaluate, translate and process relevant safety information reports for both domestic and foreign ADRs using the Medical and Scientific Information electronic database
Identify and request additional information on ADRs cases when need be.
Using Knowledge of Health Canada PV requirements, apply these requirements to day-to day activities.
Submits applicable ADRs to MHPD/VDD as per MHPD guidelines
Submits applicable ADRs to cross-license companies as per PV agreements
Apply and/or develop processes and SOPs
Prepares draft Periodic Safety Update Reports
Support and participate in activities related to Pharmacovigilance audits and inspections
Work closely with other collaborators, both within the organization and outside
Supports the Pharmacovigilance Manager according to punctual needs.
May be ask to support MI activities according to punctual needs.

 Education and  Training

• University graduate: Science (Pharmacist, MD, nurse, PhD or equivalent)
• 3-5 years in Pharmacovigilance or equivalent experience

Skills, Knowledge and Abilities

• Ability to work independently, detail oriented, ability to handle multiple tasks, ability to meet thight deadlines
• Fully bilingual, excellent oral/written communication and presentation skills
• Phone skills, customer service oriented
• Organization, adaptability and creativity
• Problem solving, team player, coordination skills
• Knowledge of pharmaceutical, and of the industry's laws and regulations
• Computer skills (MS-Office, Internet expertise)

"