specialists in pharmacovigilance (Sr.)

FOP CONSULTANTS is looking for specialists in pharmacovigilance at the senior level motivated to deliver on mandates for its clients in the pharmaceutical and biopharmaceutical sector. The mandate is to process and assess adverse event reports, submit reports to the authorities and detect safety signals and to contribute to periodic reports and risk management plans in compliance with GVP and Health Canada requirements. The senior scope is further to define the pharmacovigilance system and the risk management plan and to mentor intermediate consultants and review their reports.

• Receive, assess and enter adverse event reports.
• Code cases (MedDRA) and assess their causality and seriousness.
• Submit expedited reports to the authorities within the required timelines.
• Perform signal detection and contribute to periodic reports (PSUR/PBRER).
• Contribute to risk management plans and risk minimization measures.
• Maintain procedures, the safety database and compliance with GVP.
• Collaborate with medical affairs, regulatory affairs and partners.
• Define the pharmacovigilance system and the risk management plan.
• Mentor intermediate consultants and review their reports.
• Act as the point of contact for health authorities.

• Bachelor's or master's degree in science (pharmacology, pharmacy, chemistry, biochemistry, biology, pharmaceuticals, drug development, etc.), or any other related discipline;1 (one) to 10 (ten) years of industry experience, preferably in the (bio)pharmaceutical sector.
• Minimum ten (10) years of industry experience.
• Eight (08) to fifteen (15) years of experience as a Specialist in Pharmacovigilance.
• Sector standards: GMP (Health Canada), FDA 21 CFR 210-211, ICH Q7 to Q10, GAMP 5, ISO 9001.
• Tools and systems: MS Office suite, Argus Safety, ArisGlobal, MedDRA, EudraVigilance.
• Hold one of the following certifications: Pharmacovigilance training, GCP (ICH E6), MedDRA.
• The following are considered assets: RAC (RAPS), epidemiology certification.
• Experience in Canadian public or private organizations.
• Language: French and English

• Remote, Hybrid, On-site

At FOP CONSULTANTS, we invest in the success and well-being of our experts. By joining our team, you benefit from an environment designed to support your performance and respect your work-life balance, including:

• Competitive compensation that reflects your expertise;
• Complete protection through our group insurance plans;
• Professional liability insurance so you can practise with confidence;
• Remote-work flexibility, based on client needs;
• 3 weeks of vacation to recharge;
• 3 paid sick days, to take care of yourself;
• A monthly allowance for your transportation costs;
• Real opportunities for advancement within the organization;
• Ongoing access to training to grow your skills.