Project Leader Medical Safety -Toronto, Canada. Drives the process for the collection, assessment, reporting and filing of adverse events from both pre and post marketing products
Requisition Start Date: ASAP
Employment Type: Full-Time, Permanent Position
Location: Toronto, Ontario
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Project Leader Medical Safety . Responsibilities
- Drives the process for the collection, assessment, reporting and filing of adverse events from both pre and post marketing products
- Processes serious adverse event data from event data from clinical trials and adverse events.
- Coordinates the Medical Safety activities for the preparation of deliverables such the annual IND, DSUR, IBs and DSMB reports.
- Assists with the development and maintenance of Risk Management Plans.
- User administration, approvals and technical expertise for the Safety Database.
- Prepares safety outputs for Inclusion in Clinical Study Reports and Integrated Safety summaries.
- Establishes work plans, schedules wok and assigns to business partners involved in PV activities and safety surveillance as required.
- Liaises with CDM, Regulatory Affairs and Clinical Research to ensure PV project timelines are met and that Pharmacovigilance regulations/guidelines for both domestic and international markets are followed.
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Project Leader Medical Safety . Requirements
- B.A. or B.sc Msc. In Pharmacy, Nursing or related health sciences preferred.
- Minimum 5 years pharmacovigilance experience.
- In depth understanding of relevant safety and pharmacovigilance guidelines as well as relevant clinical trials regulations.
- Experience with safety databases (ARGUS preferred).
- Experience with medical terminology (e.g. MedDRA and WHODRUG).
- Demonstrated ability with computer software packages; MS Office Suite, Adobe Acrobat Exchange and Safety Database software.
- Strong interpersonal and verbal/written communication skills.
- Demonstrated effective organization and time-management skills. Ability to manage multiple priorities in an efficient manner under pressure.
- Proven ability in the implementation of new initiatives and receptive to change in demands and workload.
- Ability to establish and maintain effective working relationships with coworkers, management and customers
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Seniority Level
Mid-Senior level
Industry
- Pharmaceuticals
- Biotechnology
- Medical Device
Employment Type
Full-time
Job Functions
- Other
- Project Management
- Science
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