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Senior Scientist, Risk Management – Safety Surveillance
ClinChoice. Deliver scheduled and ad hoc aggregate safety reports and serve 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, aggregate safety analysis, and regulatory compliance, with strong capabilities in clinical/medical writing and risk management. Proven ability to collaborate with cross-functional teams and deliver high-quality safety reports and analyses.
Highest-signal resume keywords
PharmacovigilanceAggregate Safety AnalysisClinical/Medical WritingRisk Management Plan CreationDrug Development Principles
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 ReportsDatabase SearchesCase-Level ReviewsSafety AnalysesProject ManagementSafety Deliverables CoordinationRegulatory ComplianceSignal ValidationLiterature ReviewsHealth-Authority Queries
Soft Skills
Verbal CommunicationWritten CommunicationCollaborationLeadershipGuidance
Industry Keywords
Pharmacovigilance AgreementsPBRERPSURDSURDrug Risk-Benefit AssessmentGlobal Safety RegulationsClinical Practice ExperienceHealth or Biomedical Science DegreeStakeholder EngagementCross-Functional Training
About the role
Key responsibilities & impact- Deliver scheduled and ad hoc aggregate safety reports and serve as report owner for assigned medium- to large-volume, standard-complexity reports
- Maintain in-depth product knowledge and support Safety Management Team deliverables
- Plan and conduct meetings, database searches, aggregate safety analyses, case-level reviews, writing, and project management/coordination of strategic safety documents
- Partner with team members, Medical Safety Officers, stakeholders, and vendors
- Ensure timely, high-quality reports and safety analyses
- Collaborate with the Therapeutic Area Safety Head, Medical Safety Officer, Safety Surveillance Physician, and other stakeholders on strategy development
- Initiate, conduct, and oversee internal and external database searches
- Perform and/or lead aggregate safety analysis and case-level review
- 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 Safety Management Team meetings
- Provide guidance on Risk Management Plan creation and updates
- Lead PBRER strategy and review/align approvals for PBRERs, PSURs, DSURs, and other safety documents
- Respond to health-authority queries and prepare Marketing Authorization Holder comments
- Participate in labeling updates, signal validation and evaluation, Investigator’s Brochure safety-section updates, literature reviews, Product Safety Strategy updates, level 2 escalations, and cross-functional meetings
- Recognize and escalate potential safety issues
- Review regulatory assessor comments and requests
- Participate in cross-functional training, departmental meetings, trainings, and initiatives
Requirements
What you’ll need- Bachelor’s degree in Health or Biomedical Science and six to eight years of industry experience or equivalent
- Alternatively, an advanced degree in Health or Biomedical Science and four to six years of industry experience or equivalent (advanced degree preferred)
- Physician (MD or equivalent) generally requires 2–5 years of pharmacovigilance or other relevant experience; demonstrated clinical medicine skills with at least 3 years of clinical practice experience preferred
- Strong English verbal and written communication skills
- Clinical/medical writing or pharmacovigilance experience preferred
- Knowledge of drug development principles, drug risk-benefit assessment, safety assessment of marketed and in-development drugs, and global safety regulations highly preferred
Benefits
Comp & perks- Permanent position
- Professional development
- Excellent work-life balance
- Quality-focused, collaborative “one-team” culture
- Cross-functional training
- Departmental meetings and trainings
- Participation in department and/or cross-functional initiatives