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Pharmacovigilance Risk Management Specialist
Valide du: 10/09/2019 au 11/09/2019
JAMP Pharma is a privately owned company headquartered in Boucherville, Quebec. We are the fastest growing generic drug supplier in Canada. JAMP’s portfolio includes natural health products from its other divisions such as; Wampole, Laboratoire Suisse, Cosmetic Import and Rx products from Orimed Pharma.
• Allows you to develop professionally and have a concrete impact on the company’s success
• Fast, agile, entrepreneurial and friendly work environment
• Stable and successful privately owned company with a lot of ambition where innovation is valued
• Brand new bright and welcoming offices
• Socially committed to both employees and the community
We are currently looking for a Pharmacovigilance Risk Management Specialist to join our team in the Medical Information & Pharmacovigilance department. Reporting to the Chief, Medical Information & Pharmacovigilance, you manage the implementation and maintenance of risk management plans and related activities. In addition, you perform activities related to pharmacovigilance, such as signal detection and medical review of adverse reaction cases.
• Prepare and update risk management plans
• Implement and monitor monitoring commitments on MTRs (including educational materials)
• Train the company’s key functions on RMPs
• Conduct a medical review of adverse event cases
• Conduct a medical review of serious risks identified during surveillance activities related to regulatory actions taken in Canada and abroad
• Prepare/review synthesis reports (PSURs, PBRERs and reports related to a concern)
• Prepare/review Health Canada’s requested post-market benefit and risk assessments in Canada
• Prepare/review internal assessments on potential risks related to a product quality issue
• Participate in the development of patient support programs (PSP)
• Participate in the quarterly evaluation of product signal detection
• Participate in Pharmacovigilance inspections and audits
• All other related tasks related to RMPs
YOU MUST HAVE
• Bachelor’s degree in Pharmacy (B. Pharm.) or Medicine (M.D.)
• 10 years in the pharmaceutical industry, mainly in pharmacovigilance or medical information
• Knowledge of Canadian regulations
• Excellent knowledge of Good Pharmacovigilance Practices
• Good writing skills and rigour
• Perfect English-French bilingualism, oral and written
• Able to communicate clearly
• Ability to make decisions and communicate them with tact and diplomacy
• Mastery of Microsoft Office Suite software
Are you interested? Let’s make history together!
Apply now! firstname.lastname@example.org
Take note that only selected candidates will be contacted.