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Safety & PV Specialist I – Case Processing
Syneos HealthSafety and pharmacovigilance specialist processing clinical and post-marketing drug-safety cases for Syneos Health. Coding ICSRs, maintaining safety databases, and supporting regulatory reporting.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Pharmacovigilance and Safety Reporting, with proficiency in Safety Database systems and a strong understanding of ICH GCP and GVP regulations. Capable of managing ICSR processing, coding, and compliance with regulatory requirements while maintaining high accuracy and attention to detail.
Highest-signal resume keywords
PharmacovigilanceSafety Database SystemsICH GCP KnowledgeICSR ProcessingMedical Terminology
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
ICSR ProcessingMedDRA CodingDrug CodingData EntryLiterature ScreeningRegulatory ReportingQuality ReviewSafety TrackingNarrative SummariesSPOR/IDMP Activities
Soft Skills
Excellent CommunicationInterpersonal SkillsOrganizational SkillsDetail OrientedAbility to Work Independently
Tools & Technologies
Microsoft Office SuiteVisioOutlookTeam ShareSafety Tracking Systems
Certifications & Qualifications
Bachelor’s Degree in Life ScienceRegistered NursePharmacist
Industry Keywords
Clinical Trial ProcessPost-Marketing SafetyRegulatory CompliancePharmacovigilance System Master FileGVP Regulations
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Enter information into PVG quality and tracking systems for receipt and tracking of ICSR
- Assist in processing ICSRs according to SOPs and project/program-specific safety plans
- Triage ICSRs and evaluate data for completeness, accuracy, and regulatory reportability
- Enter data into the safety database
- Code events, medical history, concomitant medications, and tests
- Compile complete narrative summaries
- Identify information to be queried and follow up until queries are satisfactorily resolved
- Assist in generating timely, consistent, and accurate expedited reports according to regulatory requirements
- Maintain safety tracking for assigned activities
- Perform literature screening and review for safety
- Perform drug coding and maintain the drug dictionary
- Perform MedDRA coding
- Validate and submit xEVMPD product records, including coding indication terms using MedDRA
- Manually recode un-recoded product and substance terms from ICSRs
- Identify and manage duplicate ICSRs
- Perform activities related to SPOR/IDMP
- Conduct quality review of ICSRs
- Ensure relevant documents are submitted to the TMF and Pharmacovigilance System Master File as appropriate
- Maintain compliance with SOPs, WIs, regulations, GCP, ICH guidelines, GVP, project/program plans, and the drug development process
- Foster professional working relationships with project team members
- Participate in audits as required
- Apply Syneos Health regulatory intelligence to safety reporting activities
Requirements
What you’ll need- Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience
- Safety Database systems and knowledge of medical terminology
- Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements
- Knowledge of ICH GCP, GVP and regulations related to Safety and Pharmacovigilance
- Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, Outlook, Team Share or another management/shared content/workspace, and internet
- Ability to work independently and in a team environment
- Excellent written and spoken communication and interpersonal skills
- Good organizational skills with proven ability to prioritize and work on multiple tasks and projects
- Detail oriented with a high degree of accuracy and ability to meet deadlines
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture
- Comprehensive resources including emerging technologies, data, science and knowledge sharing
- Collaborative work with diverse teams of experts
- Opportunities for career paths and employment progression