Career Connections Canada Inc.
'Connecting great people with great companies'
Our pharmaceutical client in Brampton is presently looking for a Manager, Pharmacovigilance & Drug Safety to join their team.
What Our Client Offers:
- A safe and clean; GMP regulated work environment
- Opportunities for career growth and development
- A competitive wage/salary
- Incentive bonus programs that are designed to reward employees for their individual contributions
- Benefit programs designed to support our employees and their families, including a comprehensive health & dental benefits package, group RRSP matching program, direct access to healthcare and well-being programs, and paid time off
- Employee training and organizational development programs including tuition reimbursement, internal mobility programs, and employee recognition programs
Manage all pharmacovigilance activities including Adverse Event (AE) management, Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs) and Signal detection. Support business objectives by providing timely, balanced and comprehensive information on marketed products in order to promote safe, rational and effective use of products.
Principal Duties and Responsibilities :
- Manage all Canadian pharmacovigilance (PV) activities and provide complete adverse event (AE) case management including receipt of AE reports, case follow-up and closure for domestic adverse events in compliance with company SOPs, Canadian and international regulations
- Assess seriousness, expectedness and relatedness to ensure timely regulatory reporting to Health Canada
- Assessment, investigation, documentation, medical evaluation and processing of incoming Adverse Drug Events (ADEs) or Reactions (ADRs). Review cases for expectedness and seriousness using either the local Product Monographs or investigator brochures as needed.
- Manage telephone reports of ADEs/ADRs from consumers, marketing partners, health care professionals, sales & marketing, customer care, regulatory agencies, etc. including necessary follow-up correspondence.
- Review relevant medical/scientific literature and prepare required AE reports based on literature sources.
- Responsible for the preparation of the AE reports for regulatory submissions.
- Exchange relevant adverse event, drug safety and pharmacovigilance material with affiliates worldwide
- Perform quality review for products on Periodic Safety Update Reports (PSURs), Risk Management Plans and Signal Evaluation Reports to ensure accuracy and completeness.
- Manage PV/MI (medical information) service provider to ensure compliance to contractual agreement and regulations
- Review pharmacovigilance agreements with license partners and distributors and ensure timely data exchange with affiliates and partners
- Keep current with drug regulations, revising SOPs and working instructions, and labeling updates.
- Provide medical and technical information related to products to healthcare professionals.
- Prepare and plan Health Canada pharmacovigilance inspection in coordination with QA/QC department to ensure successful results.
- Develop and conduct medical training for sales force as needed.
- Review marketing literature and promotional materials for accuracy as needed.
- Perform other related duties as assigned.
- Work with Marketing, providing medical direction in the development and review of promotional material as needed
- Participate in market support activities (including assisting in sales training and product launches) as needed.
- Communicate effectively with internal staff (e.g., Sales and Marketing) to ensure appropriate use of medical information and drug safety for the benefit
Knowledge, Skills and Abilities
- Bachelor of Science Degree in Pharmacy, Nursing, Biomedical Science or Medical Degree.
- Three to Five years related experience.
- Previous experience interacting with Health Canada or other regulatory agencies.
- Excellent written and verbal communication skills.
- Strong analytical and research skills.
- Strong interpersonal skills with the ability to build strong working relationships with key stakeholders.
- Ability to handle competing priorities.
- Can present medical and technical information in a clear and understandable manner.
- Computer literate and proficient in: Lotus Notes, Microsoft Word and Excel.
- Comfortable using PV tools including MedDRA, Medline and Health Canada drug databases.
- Prior experience in a drug/medical information position, preferably within the Canadian pharmaceutical industry
- Bilingual (French) an asset
***Career Connections Canada Inc. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. To request an accommodation, please contact Career Connections Canada Inc.