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Senior Scientist, Risk Management – Safety Surveillance
ClinChoice. Deliver scheduled and ad hoc aggregate safety reports and act as report owner for assigned medium-to-large volume, standard-complexity reports .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmacovigilance, safety reporting, and risk management, with a strong foundation in drug development principles and regulatory compliance. Proficient in clinical/medical writing and effective communication within cross-functional teams.
Highest-signal resume keywords
PharmacovigilanceAggregate Safety AnalysisClinical/Medical WritingDrug Development PrinciplesSafety Assessment
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Aggregate Safety ReportingCase-Level ReviewRisk Management Plan CreationSignal EvaluationPBRER/PSURHealth-Authority QueryLiterature ReviewDatabase SearchesSafety Strategy CoordinationSafety Management Support
Soft Skills
Strong Verbal CommunicationStrong Written CommunicationCollaborationMeeting FacilitationProblem Recognition
Industry Keywords
Pharmacovigilance AgreementsSafety Management TeamTherapeutic Area SafetyGlobal Safety RegulationsClinical Development Teams
About the role
Key responsibilities & impact- Deliver scheduled and ad hoc aggregate safety reports and act as report owner for assigned medium-to-large volume, standard-complexity reports
- Maintain in-depth product knowledge and support Safety Management Team deliverables
- Plan activities, conduct meetings, search databases, perform aggregate safety analysis and case-level review, write documents, and coordinate strategic safety projects
- Collaborate with Therapeutic Area Safety Head, Medical Safety Officers, Safety Surveillance Physician, vendors, and other stakeholders on safety strategy
- Ensure timely, high-quality safety reports and analyses
- Initiate, conduct, and oversee internal and external database searches
- Author, contribute to, and coordinate core safety deliverables
- Ensure Pharmacovigilance Agreements and assessment-report commitments are met
- Provide Safety Management Team support and lead assigned meetings
- Guide risk management plan creation and updates
- Lead or support PBRER/PSUR, health-authority query, signal evaluation, DSUR, labeling, literature-review, Product Safety Strategy, and escalation activities
- Participate in cross-functional training, departmental meetings, Clinical Development Teams, Local Working Groups, and other initiatives
- Recognize and escalate potential safety issues and address regulatory assessor comments and requests
Requirements
What you’ll need- Bachelor’s degree in Health or Biomedical Science and six to eight years of industry experience or equivalent
- Advanced degree in Health or Biomedical Science and four to six years of industry experience or equivalent (preferred)
- Physician (MD or equivalent) generally requires 2–5 years of pharmacovigilance or other relevant experience
- At least 3 years of clinical practice experience for physicians (preferred)
- Clinical/medical writing or pharmacovigilance experience (preferred)
- Strong English verbal and written communication skills
- Knowledge of drug development principles, assessment of drug risks and benefits, safety assessment of marketed and in-development drugs, and global safety regulations (highly preferred)
Benefits
Comp & perks- Professional development and continuous training
- Work-life balance
- Quality-focused, collaborative “one-team” culture
- Equal opportunity and inclusive, barrier-free recruitment and selection processes
- Accommodation for qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act