About this role
- 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.
- 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.
What we offer
Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.
Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.
- Publication: PUB264632
- Location: Toronto
- Market: Life Sciences & Health Care
- Hours per week: 40
- Branche: Pharmaceutical
- Education level: Academic Bachelor
- Area of Expertise: Regulatory
- Closing date: Sunday, June 7, 2020
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