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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in product safety leadership, including the development of Safety Management Plans and oversight of safety data collection and reporting. Proficient in managing safety communications, risk assessments, and compliance with global pharmacovigilance regulations.
Highest-signal resume keywords
Product Safety LeadershipSafety Management Plans DevelopmentPharmacovigilance ExperienceArgus ProficiencyRegulatory Compliance Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Safety Data CollectionSafety Data ProcessingSafety Data ReportingRisk AssessmentMedDRA CodingWHO Drug CodingClinical Trials ManagementInspection-Ready DocumentationBudget ManagementTimeline Management
Soft Skills
Effective CommunicationTeam CollaborationJudgment in Complex SituationsAttention to DetailMentoring Skills
Tools & Technologies
ArgusExcelWordPowerPoint
Certifications & Qualifications
Bachelor's DegreeRNHealth SciencesPharmD
Industry Keywords
Product SafetyPharmacovigilanceClinical ResearchGlobal Regulatory RequirementsSafety Governance
About the role
Key responsibilities & impact- Serve as primary Product Safety Lead for assigned moderate- to high-complexity studies
- Lead study-level safety governance, including planning, execution, and oversight of safety data collection, processing, and reporting
- Develop, author, and maintain study-specific Safety Management Plans
- Act as primary Product Safety contact for sponsors and internal project teams
- Manage safety-related communications and issue resolution
- Lead study-level safety meetings, document decisions, and track action items
- Manage study-level safety scope, timelines, and budgets
- Identify and escalate risks affecting deliverables, quality, or compliance
- Oversee safety start-up and close-out activities and maintain inspection-ready documentation
- Guide Product Safety Specialists and Associates, including reviewing deliverables and escalating complex issues
- Support proposal development and bid defenses with study-level safety strategy and operational input
- Conduct preliminary or routine risk assessments
- Participate in training and mentoring junior safety team members
Requirements
What you’ll need- Bachelor’s degree (e.g., RN, Health Sciences, PharmD) or equivalent combination of education and relevant product safety or clinical research experience along with 5+ years of product safety/pharmacovigilance experience
- 2 years of experience working as a Product Safety Lead on Clinical Trials is required, including developing Safety Management Plans and site training materials and supporting inspections
- Experience with Argus is preferred; proficient in the use of business productivity software (Excel, Word, PowerPoint, etc.)
- Strong knowledge of safety data collection, processing and reporting requirements
- Strong knowledge of global regulatory requirements for pharmacovigilance
- Advanced knowledge of safety database applications and MedDRA/WHO Drug coding
- Proficiency in both English and local language
- Effective verbal and written communication and presentation skills
- Ability to work effectively and collaboratively within a team environment
- Strong judgment in complex or ambiguous situations
- Advanced attention to detail, including identifying issues, inconsistencies, or risks and ensuring work products are thorough and reliable