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
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.
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
If you’re looking new job opportunities that offer relocation and high
salaries around the world check it out on our website Jobzey.com
- Medical Device
- Project Management
LOOKING for a JOB? Follow me. Not because I am an Influencer but because I sincerely care. I want to bring change to the recruiting process.
Even if one person gets a job, I would be the happiest person. Job searching is emotionally draining. No one should have to go through this alone.
I think everyone should support jobseekers’ posts. It takes a second, but may change someone’s life. LinkedIn isn’t only about entertainment. It’s about networking.
Let’s help each other out! “We cannot help everyone, but everyone can help someone.
To apply for this job please visit www.linkedin.com.