Patient Safety Associate I – Drug Safety Associate I

Parexel

. Monitor incoming safety reports from multiple sources and support timely processing of pharmacovigilance data .

Posted 10/7/2026full-timeRemote • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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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 ProcessesDrug Safety RegulationsCase ProcessingVeeva Safety ExperienceMS Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data EntryCase CreationQuality ChecksCodingLiterature SearchesIndividual Case Safety ReportsRegulatory ReportingSafety Information ExchangeData ReconciliationLifecycle Management

Soft Skills

Attention To DetailOrganizational SkillsProblem SolvingEffective CommunicationTeam Collaboration

Tools & Technologies

Safety DatabasesEDMSETMFPharmacovigilance Systems

Industry Keywords

Life SciencesHealth SciencesBiomedical SciencesPost MarketingTherapeutic Areas

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 processing, documentation, reconciliation, and tracking of safety cases and submissions
Conduct literature searches, screen and review scientific literature, and identify potential safety information
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 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

Requirements

What you’ll need

Bachelor’s degree in Life Sciences, Health Sciences, 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 (cardiology, neurology, oncology, 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 MS Office and ability to learn safety systems/databases
Preference for those with Veeva Safety experience
Experience working with pharmacovigilance systems, databases, and established workflows

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
Flexible work from home arrangement in the US