The Pharmacovigilance Associate is responsible for:
Maintaining an efficient vigilance system in compliance with the national regulations for human and veterinary drugs, and for biological products
Participating in other vigilance processes (e.g., Post marketing activities / Clinical trial activities / Training)
Ensuring appropriate contacts with Regulatory Affairs, Quality.
Post-marketing activities:
Collect, follow-up, transmit all local adverse events (AEs), and pregnancy cases, to Global Pharmacovigilance.
Enter local cases into the local tracking system.
Process cases in accordance with Global and Local Pharmacovigilance procedures.
Answer queries and requests from Global Pharmacovigilance.
Answer ADR and ADR case processing questions from local Regulatory Authorities and Health Care Professionals.
Submit the reportable ADRs, (local & foreign) to the local Regulatory Authorities according to the national regulations and answer any subsequent questions in collaboration with the Global Pharmacovigilance.
Assist the Director Pharmacovigilance in developing and maintaining the local Pharmacovigilance SOPs and Work Practice Documents.
Maintain Safety Summaries from Global Pharmacovigilance for Canadian licensed products and to submit to Health Canada, upon request.
Provide input into labeling changes to the Regulatory Affairs Department.
Develop updated list of all Canadian drug licensing status and renewals, in conjunction with Regulatory Affairs.
To identify all local safety observational studies (Post-Authorization Safety Studies), in conjunction with Regulatory Affairs.
Clinical trials activities:
Submit the expedited Serious Adverse Events, new events and reports to the Health Canada according to the national regulations.
Inform Global Pharmacovigilance on all new local clinical trials and transmit the protocol.
Local regulations:
To maintain current knowledge or all relevant local regulations in regards to human and veterinary drugs and biological products.
To participate in the screening of Health Canadas website in conjunction with Regulatory Affairs.
Training:
Participate in the training in vigilance procedures of all appropriate customer-facing employees.
Other:
To provide translation of French source documentation, as appropriate.
EDUCATION & EXPERIENCE:
Education Level - Science degree B.Sc. or M.Sc.
Major Subjects/Specialties
Pharmacy, Chemistry, Biology, Pharmacology
Years Of Experience:
5-8 years RA or MV experience.
Additional Skills/ Special Training Required:
Excellent written and verbal communication skills
Strong time management skills
Excellent computer and database management skills
We thank all applicants for their interest; however only those individuals selected for an interview will be contacted.
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