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Senior Scientist, Risk Management & Safety Surveillance
Contract type
Ongoing
Work mode
Remote · Canada
Experience
Senior · 6+ years
Job description
Senior Scientist, Risk Management & Safety Surveillance in ClinChoice's in-house pharmacovigilance team, responsible for core safety deliverables including aggregate reports and safety analyses.
At a glance
- Employment
- Full-time · Employee (employment agreement)
- Work mode
- Remote · Canada
- Languages
- English – fluent
- Apply before
- November 6, 2026
What you'll do
- Ensure timely, quality reports/safety analyses related to core deliverables with oversight as appropriate
- Collaborate with Therapeutic Area Safety Head (TASH), MSO, Safety Surveillance Physician (SSP) and other stakeholders on strategy development
- Initiate, conduct, and oversee searches of internal and external databases
- Perform and/or lead aggregate safety analysis and case level review
- Author, contribute, and coordinate the preparation of core safety deliverables
- Ensure commitments (e.g., Pharmacovigilance Agreements (PVAs) and assessment reports) are met
- Partner with vendor to develop reports/deliverables
- Provide SMT support as needed
- Act as ad hoc member for assigned products as appropriate
- Recognize potential issues and or safety issues and escalate to the attention of the report owner, line manager, or MSO
- Review regulatory assessor comments/requests and accommodate/address as appropriate with guidance
- Participate in cross-functional training of relevant stakeholders
- Attend departmental meetings and trainings
- Participate in department and/or cross-functional initiatives
- Lead SMT meetings and drive discussions and formulate decisions along with core members
- Provide guidance on RMP creation and updates and review and align approvals with oversight leads
- Review and align approvals for PBRER/PSUR with lead oversight and lead strategy of the PBRER process
- Work with MSO and scientist on health authority queries to organize data, review cases, literature, and write MAH comments
- Participate in label working group and provide guidance related to CCDS, US and EU prescribing information updates
- Work with Scientist to review preliminary data to determine if a signal is valid and lead the signal evaluation process
- Evaluate clinical data for ADRs and assist with section 5 and RSI tables for IB updates
- Review and align Safety approvals for DSURs with lead oversight
- Provide support with review and characterization of risks and data review for Addendum to Clinical Overviews
- Review articles and create MAH Comments for assessment of the articles for literature reviews for class effects and ad hoc reports
- Review risks documented in the PSS and oversee updates as necessary
What we're looking for
- Bachelor's degree in Health or Biomedical Science and six to eight years of industry experience or equivalent, or Advanced degree in Health or Biomedical Science and four to six years of industry experience or equivalent
- Physician (MD or equivalent) generally requires 2-5 years of pharmacovigilance experience or other relevant experience (e.g., Clinical research, Medical Affairs)
- Demonstrated skills in clinical medicine with at least 3 years of clinical practice experience is preferred
- Strong English verbal and written communication skills
- Ability to understand nature of adverse drug reactions and complex associations
- Attention to detail and ability to analyze data in broader context
- Ability to work across multiple functions and therapeutic areas
- Maintains a high level of flexibility and ability to reprioritize one's work and others
Nice to have
- Clinical/medical writing or pharmacovigilance experience preferred
- Demonstrated knowledge of principles of drug development, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development as well as global safety regulations, is highly preferred
Your team
Risk Management & Safety Surveillance
In-house pharmacovigilance team working with Medical Safety Officers, Safety Surveillance Physicians, Therapeutic Area Safety Heads and a vendor
How to get hired
- 1Submit CV and receive an acknowledgement
- 2Phone interview as the first step
- 3AI screening for keywords and minimum qualifications; recruiters review all results
Apply
About ClinChoice
Global full-service CRO specializing in clinical development and functional solutions
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.
Mission
To contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices
Key facts
- over 4,000 professionals
- Contract Research Organization (CRO)
- Over 28 years of proven high-quality delivery and results across all our services
- Over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific
- Below industry average turnover rates
What they value
- Diversity and inclusivity
- Continuous training
- Close management and training