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Drug Safety Specialist
TEKsystems. Perform end-to-end processing of Individual Case Safety Reports (ICSRs) .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in end-to-end processing of Individual Case Safety Reports (ICSRs) and managing Adverse Events (AEs) and Serious Adverse Events (SAEs) within pharmacovigilance. Proficient in regulatory compliance, safety reporting, and collaboration with cross-functional teams.
Highest-signal resume keywords
Pharmacovigilance ExperienceAdverse Event ReportingSignal DetectionAggregate Safety Reports PreparationFDA Regulations Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
End-to-End ICSR ProcessingSafety Case ReviewReportability AssessmentPost-Marketing Safety ActivitiesClinical Trial Safety Activities
Soft Skills
Organizational SkillsAnalytical SkillsProblem-Solving SkillsWritten Communication SkillsVerbal Communication Skills
Tools & Technologies
Pharmacovigilance DatabasesArgusArisGOracle Safety
Certifications & Qualifications
PharmDRNMD
Industry Keywords
Individual Case Safety ReportsAdverse EventsSerious Adverse EventsSuspected Unexpected Serious Adverse ReactionsICH GuidelinesSOPsPADERsPSURsDSURs
Tech Stack
Tools & technologiesOracle
About the role
Key responsibilities & impact- Perform end-to-end processing of Individual Case Safety Reports (ICSRs)
- Receive, document, evaluate, and process Adverse Events (AEs), Serious Adverse Events (SAEs), and Suspected Unexpected Serious Adverse Reactions (SUSARs)
- Conduct follow-up with healthcare professionals, patients, and other reporters to obtain complete case information
- Perform medical review activities and reportability assessments
- Support submissions to regulatory authorities and maintain compliance with reporting timelines
- Perform reconciliation activities related to safety cases and reporting
- Assist with preparation and review of aggregate safety reports, including PADERs, PSURs, and DSURs
- Support signal detection and signal management activities
- Collaborate with cross-functional internal teams, external partners, and vendors
- Maintain compliance with company SOPs, pharmacovigilance procedures, FDA regulations, and ICH guidelines
- Support audits, inspections, process improvements, and pharmacovigilance documentation activities
Requirements
What you’ll need- Bachelor's degree in Life Sciences, Pharmacy, Nursing, Healthcare, or a related scientific discipline
- Minimum 3-5 years of Pharmacovigilance and/or Drug Safety experience within a pharmaceutical, biotechnology, or CRO environment
- Hands-on experience performing end-to-end ICSR case processing
- Experience managing Adverse Event (AE) and Serious Adverse Event (SAE) reporting
- Experience supporting post-marketing safety and/or clinical trial safety activities
- Working knowledge of FDA regulations and ICH guidelines
- Experience conducting safety case review and assessment activities
- Strong organizational, analytical, and problem-solving skills
- Excellent written and verbal communication skills
- Ability to work independently in a fully remote environment
- PharmD, RN, MD, or other advanced healthcare/scientific degree preferred
- Experience with signal detection and safety surveillance activities preferred
- Experience preparing or supporting aggregate safety reports (PADER, PSUR, DSUR) preferred
- Experience with pharmacovigilance databases such as Argus, ArisG, Oracle Safety, or similar systems preferred
- Experience participating in audits, inspections, or quality/compliance initiatives preferred
- Experience managing post-marketing drug safety activities preferred
Benefits
Comp & perks- Medical, dental & vision
- Critical Illness, Accident, and Hospital coverage
- 401(k) Retirement Plan with pre-tax and Roth post-tax contributions
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short- and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
- 100% remote opportunity
- Contract-to-Hire career path
- Collaborative and growth-oriented team environment