Specialist/Project Manager, pharmacovigilance
2 weeks ago
In order to meet the needs of its clients in the (Bio)Pharmaceutical sector, FOP CONSULTANTS is looking for pharmacovigilance consultants to carry out various mandates. The main missions would be to manage projects on adverse drug reactions, participate in the training of personnel on pharmacovigilance guidelines, participate in the drafting of pharmacovigilance documents and collaborate on any project involving pharmacovigilance related to pharmaceutical products.
Main responsibilities:Without limitation, the main tasks involve:
- Manage projects involving adverse effects from different product sources;
- Identify, collect, process and report data on adverse effects;
- Report and submit reportable adverse reactions to manufacturers, in accordance with Health Canada regulations and customer guidelines, and follow up as required. Ensure that all regulatory aspects are taken into account during the execution of projects;
- Properly document and archive all drug safety information and source documents;
- Monitor standards and compliance targets with respect to reporting timelines, quality of reports, and inquiries from stakeholders and manufacturers;
- Organize and ensure the accuracy of pharmacovigilance information for a variety of manufacturers and patient care programs, including preparing for audits;
- Participate in the drafting and review of standard operating procedures (SOPs) related to pharmacovigilance and participate in training and train staff on pharmacovigilance procedures;
- Support less experienced staff with technical expertise;
- Participate in weekly or monthly meetings on pharmacovigilance files;
- Provide solutions to problems encountered and perform all tasks relevant to the mandate.
- 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;
- Project management (an asset);
- Demonstrated experience in pharmacovigilance in the pharmaceutical field;
- Knowledge of regulations (Health Canada, FDA, EMA);
- Excellent skills in MS Office Suite;
- Good communication and writing skills in French and English;
- Mobility (an asset).
- Leadership;
- Rigor et discipline;
- (Organize), able to manage several projects;
- Analytical and critical mindset;
- Perseverance;
- Humility.
In order to allow the full development of our team members, FOP CONSULTANTS guarantee the support and comfort necessary for the achievement of their mandate. The main advantages offered are as follows:
- Competitive wages;
- Group insurance;
- Professional insurance;
- Remote work, according to the customer needs;
- Vacations: 3 weeks;
- Paid sick leave: 3 days;
- Monthly transportation fees;
- Career advancement opportunity;
- Continuing education.
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