Pharmacovigilance Associate 12 month contract
Mississauga, ON, Canada
Req ID 50657BR
Business Title
Pharmacovigilance Associate - 12 month contract
Business
Global Quality
Sub-Business
Global Pharmacovigilance
Country
Canada
State/Province
Ontario
Location of Position
Mississauga, Ontario, CAN
Job Description
This is a 12 month contract position
The Pharmacovigilance Associate is responsible for:
•Maintaining an efficient vigilance system in compliance with the Health Canada regulations and guidelines for human and veterinary drugs and biologic products
•Participating in other Pharmacovigilance processes (e.g., Post-market surveillance activities / Clinical trial activities / Training)
•Ensuring appropriate contacts with Regulatory Affairs, Quality, Medical Affairs, and Global Pharmacovigilance. Post-market surveillance activities:
•To collect, pursue follow-up information to complete quality adverse event reports and transmit all local adverse events to Global Pharmacovigilance.
•To document and update case information into the global safety database.
•Analyze and process adverse events and safety reports with utmost quality and timeliness in accordance with Global and Local Pharmacovigilance procedures.
•To respond to queries and requests from Global Pharmacovigilance.
•Interact with other functional areas/departments to process adverse events efficiently & reliably.
•To submit the reportable adverse reactions to Health Canada according to their regulations and guidances
•To provide responses to questions from Health Canada and Health Care Professionals regarding adverse events cases.
•To collaborate with the Director Pharmacovigilance in developing and maintaining the local Pharmacovigilance SOPs and procedures.
•To review and submit Summary Reports to Health Canada according to their regulations and guidances
•To provide Pharmacovigilance input into labeling changes in conjunction with the Regulatory Affairs Department.
•To have at disposal an updated list of all Canadian drug licensing status and renewals, in conjunction with Regulatory Affairs.
•To identify all local safety observational studies (-e.g., Phase IV studies), in conjunction with Regulatory Affairs.
•To review and provide input into local contracts with third partners (licensing, distributor, etc.), in conjunction with Global Pharmacovigilance and maintain an updated list.
Clinical trials activities:
•To submit reportable adverse reactions to applicable divisions of Health Canada according to their regulations and guidances.
•To inform Global Pharmacovigilance on all new local clinical trials and transmit the protocol if applicable. Local regulations:
•To maintain current knowledge of all relevant local Pharmacovigilance regulations in regards to human and veterinary drugs and biological products
•To participate in the screening of Health Canada's website in conjunction with Regulatory Affairs.
•To educate internal stakeholders on the implications of existing regulations and guidance documents along with local and global procedures and policies.
•Coordinate responses to questions and requests from Regulatory Authorities Training:
•To conduct Pharmacovigilance training of new hires and appropriate customer-facing employees. Other:
•To provide support to the Director Pharmacovigilance on ongoing local and global projects.
•To participate as the Pharmacovigilance representative on local and global project teams.
•Take initiative to recognize, prioritize & escalate potential safety/compliance issues
•To author and implement Pharmacovigilance processes and procedures.
•Collaborate with relevant counterparts in global and other local Pharmacovigilance functions to facilitate the global exchange of safety knowledge.
•To provide translation of French source documentation, as appropriate.
Job Requirements
Education Level:
Required: Science degree (BSc.)
Preferred: BSc. Biology, Pharmacology; Nursing, Pharmacy
Major Subjects / Specialties:
Required: Biology, Physiology, Pathophysiology, Pharmacology
Preferred: Nursing, Pharmacy
Type of Experience:
Required: Industry experience
Preferred: Health Care, Industry, Pharmacovigilance, Quality or Regulatory experience in Canada
Years of Experience:
Required: 2 years
Preferred: 2-5 years Canadian Pharmacovigilance, Quality or Regulatory experience
Additional Skills / Special Training / Technical Skills Required:
Required:
•Capable of multi-tasking,
•Above average computer skills.
•Excellent organizational and communication skills with multiple audiences (e.g., Health Canada, internal departments, Health Care Professionals and patients).
•Operates effectively in a team environment
•Ability to work under strict deadlines and changing priorities with limited supervision
•Attention to detail
•Understanding of existing regulations and guidances Preferred:
•Word, Excel, PowerPoint skills
•French an asset
