Pharmacovigilance Specialist (12-month contract) Hybrid - Laval, QC
Responsibilities
- To perform general administrative and operational activities related to PV activities (including case tracking, data entry, document filing, and archiving, in alignment with applicable SOPs/OPMs and using PV tools.
- To maintain PV databases and documentation by ensuring timely and accurate entry, tracking, and filing of safety-related information in relevant systems.
- To prepare, submit the PV documentation to regulatory authorities in accordance with local and global regulatory requirements and file as required.
- To act as liaison during the absence of one or more members of the PV team to ensure continuous coverage and operational support under the supervision of the Deputy LPV.
- To perform delegated activities related to the Special Access Program, ensuring compliance with established procedures and timelines.
- To assist in the preparation and review of PV compliance metrics, reconciliation reports, and related documentation with internal and external stakeholders.
- To participate in PV departmental and cross-functional meetings, and follow-up actions as required.
- To ensure that all PV-related activities are conducted in compliance with applicable SOPs, OPMs and codes of practice.
- To undertake any other PV-related activities as assigned to support the overall functioning of the Local PV Department.
Requirements
- Collegiate training.
- Minimum of 3 years of pharmacovigilance experience in the pharmaceutical industry
- Fluently bilingual, spoken and written.
- Advanced expertise in Office software (Word, Excel, PowerPoint) and demonstrated ability to learn to use new software.
- Excellent self-organisation of work.
- Oriented towards teamwork.
- Capacity to work during periods of increased workload.
- Capacity to access and understand urgent situation and respond appropriately.
- Ability to respect tight deadlines.
- Adaptable to change in work environment - tools and projects.