Manager, Drug Safety
Recruiting.com
full-time
Posted on:
Location Type: Remote
Location: Canada
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Salary
💰 CA$73,400 - CA$113,190 per year
About the role
- Ensuring effectiveness of AE reporting processes, to meet and or exceed client expectations
- Identifying needs for modification of program database, drug safety database, protocols and current processes
- Leading and assisting team members assigned within the program to ensure effective results
- Collaborate in identifying training requirement needs, leading refresher adverse event training as required
- Responsible for daily and on-going client reporting and project communications
- Working with Senior Manager and program management to ensure assigned program(s) is audit ready
- Working with Quality Assurance and Senior Manager to perform regular Quality Checks for program AE reporting
- Oversee the CAPA process and activities in collaboration with Senior Manager
- Participate in the hiring and training process of new staff
- Responsible for recruitment, training, coaching and performance management of team members
- Lead by example to create strong team dynamics
- Maintaining up to date and relevant knowledge of Pharmacovigilance regulations
- Perform case triaging, evaluation including causality, severity and seriousness assessments
- Literature searches as needed
- Reconciliation of event reports
- Submit ICSR cases to Regulatory Authorities and/or our clients as applicable
Requirements
- Bilingual, English/French strongly preferred
- Health Care Professional (Nurse, Pharmacist, MD) or Bachelor’s degree in related discipline or diploma in a life sciences program
- 3-5 years’ experience in Drug Safety, Clinical Research and/or equivalent and related experience in the pharmaceutical industry
- Familiarity with Adobe Pro an asset
- Can do attitude, with proven ability to meet strict deadlines
- Knowledge of medical terminology is a strong asset
- Able to work any 8-hour shift between 8:00 AM-8 PM, if necessary
- Good internet required for remote work
Benefits
- Health insurance
- Dental care
- Vision care
- Adoption assistance
- Infertility coverage
- Family building support
- Behavioral health solutions
- Paid parental leave
- Paid caregiver leave
- Professional development resources
- Training programs
- Employee resource groups
- Volunteer activities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
PharmacovigilanceDrug SafetyClinical ResearchCase triagingCausality assessmentSeverity assessmentSeriousness assessmentEvent report reconciliationICSR submissionQuality Checks
Soft Skills
LeadershipTeam dynamicsCoachingPerformance managementCommunicationCollaborationTrainingProblem-solvingAdaptabilityDeadline management
Certifications
Bachelor’s degree in related disciplineDiploma in life sciences programHealth Care Professional (Nurse, Pharmacist, MD)