Pharmacovigilance Specialist

Pharmacovigilance Specialist (renewable contract)Remote – Quebec or OntarioIntroductionWe are hiring a Pharmacovigilance Specialist for one of our pharmaceutical clients based in either Ontario or Quebec. The Pharmacovigilance Specialist is responsible for maintaining an efficient vigilance system in compliance with the Health Canada regulations and guidelines; participating in other Pharmacovigilance processes (e.g., postmarket surveillance activities / training); ensuring appropriate contacts with Regulatory Affairs, Quality Assurance, Medical Affairs, and Global Pharmacovigilance.ResponsibilitiesAnalyze and process adverse events and safety reports with utmost quality and timeliness in accordance with Global and Local Pharmacovigilance procedures.Collect, pursue follow-up information to complete quality adverse event reports and transmit all local adverse events to Global Pharmacovigilance.Evaluate domestic and foreign ICSRs (marketed and non-marketed drugs) for submission to Health Canada according to Canadian regulations and within prescribed timelines.Submit the Canadian reportable adverse reactions to Health Canada according to their regulations and guidance’s.Respond to queries and requests from Global Pharmacovigilance.Run monthly submissions compliance report and communicate with team members.Organize and ensure maintenance of the electronic filing and archiving system according to corporate and Canadian requirements.Document and update case information into the global safety database.Interact with other functional areas / departments to process adverse events efficiently & reliably.Collaborate in developing and maintaining the local Pharmacovigilance SOPs and procedures.Update the list of all Canadian drug licensing status and renewals, in conjunction with Regulatory Affairs.Participate in training of PV Associate on their assigned activities.Support associate with inbound and outbound case management activities as needed and as per corporate and local requirements and timelines.Provide overall support to the PV on all team activities.Maintain current knowledge of all relevant local Pharmacovigilance regulations in regard to drug, natural health and cosmetics products.Coordinate responses to questions and requests from Regulatory Authorities.RequirementsBilingual French / English with great verbal and written communication.Degree within healthcare (Pharmacy or Medical Degree : B. Pharm., B.Sc. Pharm., Pharm. D, MD. (Registered nurse with university degree or University degree in science and relevant experience and competency profile may be considered))Previous experience in a similar capacityAdvanced software user3-years’ experience in a relevant Pharmacovigilance setting in the pharmaceutical industry. Other relevant experience in a Health Care setting may also be considered.Resourceful and able to take ownership of areas of responsibilityAction-oriented, able to work with constant short deadlinesAble to manage projectsSkilled with computer applicationsStrong communication skillsExcellent analytical and problem-solving abilitiesExcellent interpersonal skillsStrong organization and priority setting skillsAbility to focus on details where relevant whilst considering the global pictureWhat We OfferWhy apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you : from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We’ll get you going while you get on with the job.About UsBrunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.