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Safety & PV Specialist I
Syneos HealthAssist in safety and pharmacovigilance program delivery activities for drug development at Syneos Health. Engage in data management, literature review, and submission processes to support clinical trials.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- assist with safety and pharmacovigilance program delivery activities including collection, processing, and reporting of individual cases safety reports (ICSRs)
- literature screening for safety, drug coding, maintenance of drug dictionary, MedDRA coding
- data management activities including cleaning and validation of data
- identification of Medicinal Products (IDMP) activities and preparation of expedited and periodic safety reports
- adheres to data privacy guidelines, GCP, GVP, regulatory guidelines, company and project/program-specific procedures
- enter information into PVG quality and tracking systems for receipt and tracking ICSR
- assist in the processing of ICSRs according to SOPs
- triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability
- maintains safety tracking for assigned activities
- performs literature screening and review for safety
- ensures all relevant documents are submitted to the Trial Master File (TMF)
- participates in audits as required/appropriate
Requirements
What you’ll need- Bachelor’s Degree in life science, registered nurse, pharmacist or equivalent combination of education and experience
- 3+ years of experience in ICSR case processing
- Advanced MedDRA coding training
- knowledge of medical terminology
- Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations
- Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet
- Excellent communication and interpersonal skills, both written and spoken
- good English level
- Good organizational skills with proven ability to prioritize and work on multiple tasks and projects
- Detail oriented with a high degree of accuracy
Benefits
Comp & perks- career development and progression
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition
- total rewards program
- building an inclusive culture
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
ICSR ProcessingMedDRA CodingData CleaningData ValidationMedical TerminologyRegulatory ReportabilitySafety ReportingTrial Master File ManagementPharmacovigilanceLiterature Screening
Soft Skills
Excellent CommunicationInterpersonal SkillsOrganizational SkillsDetail OrientedAbility to Prioritize