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Drug Safety Associate
TFS HealthScience - Contract Research Organization. Support handling of serious adverse events (SAEs) in clinical trials and spontaneous market reports .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in handling Serious Adverse Events (SAEs) in clinical trials, ensuring compliance with regulatory requirements and Good Clinical Practice. Proficient in coding adverse events and drafting reports while maintaining effective communication and collaboration across departments.
Highest-signal resume keywords
Serious Adverse Events (SAEs) HandlingPharmacovigilance LegislationGood Clinical Practice (GCP) RegulationsMedical Terminology UnderstandingEudraVigilance Registration
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 Case CollectionAdverse Event CodingReport Narrative DraftingSafety Database EntrySOP Compliance
Soft Skills
Excellent Communication SkillsAbility to Work IndependentlyTeam Collaboration
Tools & Technologies
Word Processing SoftwareSpreadsheet Software
Industry Keywords
Clinical TrialsSafety ManagementRegulatory RequirementsICH GuidelinesMedical History
Tech Stack
Tools & technologiesTFS
About the role
Key responsibilities & impact- Support handling of serious adverse events (SAEs) in clinical trials and spontaneous market reports
- Ensure collection, assessment, and entry of safety cases into the safety database according to SOPs and regulatory requirements
- Review cases and draft adverse event and serious adverse event report narratives as required
- Code adverse events, medical history, and concomitant medication
- Support SAE reconciliation and DCF handling
- Manage correspondence and archiving
- Assist with EudraVigilance registration and related matters
- Participate in relevant project groups and meetings
- Provide internal support to relevant departments
- Update safety-handling templates for studies and projects according to SOPs
- Contribute to developing routines that improve work at TFS
- Stay informed about laws, directives, and guidelines concerning SAE and pharmacovigilance handling and reporting
Requirements
What you’ll need- Bachelor’s Degree, preferably in life science or nursing; or equivalent
- Able to work in a fast-paced environment with changing priorities
- Understand basic medical terminology and science associated with assigned drugs and therapeutic areas
- Basic understanding of Good Clinical Practice regulations, ICH guidelines, Pharmacovigilance legislation, and internal SOPs
- Ability to work independently and in a team matrix organization with little or no supervision
- Excellent written and verbal communication skills
- Proficiency using typical word processing; spreadsheets desirable
Benefits
Comp & perks- Opportunities for personal and professional growth
- Rewarding environment
- Collaborative team culture
- Quality-focused workplace
- Opportunity to make a difference in patients’ lives