Patient Safety Associate I – Drug Safety Associate I
Parexel
Posted: 10/21/2026
Associate Specialist, Drug Safety
MSD
Posted: 10/21/2026
Drug Safety Associate III
Exelixis
Posted: 10/9/2026Patient Safety Associate I – Drug Safety Associate I
Parexel
Posted: 10/7/2026Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmacovigilance processes, including data entry, case processing, and regulatory reporting. Proficient in maintaining safety databases and ensuring compliance with drug safety regulations across multiple therapeutic areas.
Highest-signal resume keywords
Pharmacovigilance ExperienceDrug Safety Regulations KnowledgeCase Processing SkillsVeeva Safety ExperienceAttention To Detail
About the role
Key responsibilities & impact- Monitor incoming safety reports from multiple sources and support timely processing of pharmacovigilance data
- Perform data entry, case creation, case processing, quality checks, coding, follow-up activities, and case narrative preparation in safety databases
- Support regulatory reporting through accurate processing, documentation, reconciliation, and tracking of safety cases and submissions
- Conduct literature searches, screen and review scientific literature, identify potential safety information, and support literature monitoring
- Submit Individual Case Safety Reports, periodic reports, and related documentation to regulatory authorities and stakeholders
- Support affiliate services, including safety information exchange, literature screening coordination, translation support, follow-up activities, and data reconciliation
- Maintain documentation, records, and project files in EDMS and eTMF environments
- Maintain regulatory databases, track submissions, support registrations, and assist with lifecycle management
- Research, maintain, and update country-specific safety reporting requirements and associated records
- Participate in project meetings, training programs, audits, inspections, and departmental activities
- Escalate issues to supervisors as appropriate
- Collaborate with experienced professionals across global teams to support patient safety and pharmacovigilance activities
Requirements
What you’ll need- Bachelor’s degree in Life Sciences, Health Sciences, or Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology) or equivalent education/experience
- Foundational knowledge of drug safety regulations and pharmacovigilance processes
- Ideal candidate has 3+ years experience in Drug Safety
- 2+ years experience in post marketing
- Experience in multiple therapeutic areas, including cardiology, neurology, oncology, and rare disease
- Strong attention to detail, organizational skills, and problem-solving ability
- Effective communication and willingness to work in a collaborative team environment
- Proficiency with Microsoft Office
- Ability to learn safety systems/databases
- Preference for Veeva Safety experience
- Experience working with pharmacovigilance systems, databases, and established workflows
- Interest in pharmacovigilance, patient safety, pharmaceutical development, or healthcare environments
- Commitment to quality and compliance
Benefits
Comp & perks- Health, Vision & Dental Insurance
- Tuition Reimbursement
- Vacation/Holiday/Sick Time
- Flexible Spending & Health Savings Accounts
- Work/Life Balance
- 401(k) with Company match
- Pet Insurance
- Paid time off
- Life insurance
- Additional benefit offerings in accordance with the terms of applicable plans
- Work from home flexibility in the US
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data EntryCase CreationQuality ChecksCodingLiterature SearchesIndividual Case Safety ReportsRegulatory ReportingSafety Database ManagementSafety Information ExchangeLifecycle Management
Soft Skills
Organizational SkillsProblem-Solving AbilityEffective CommunicationCollaboration
Tools & Technologies
Microsoft OfficeEDMSETMFPharmacovigilance Systems
Industry Keywords
Life SciencesHealth SciencesBiomedical SciencesPost MarketingPatient SafetyPharmaceutical DevelopmentTherapeutic AreasQuality And Compliance