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Safety & PV Specialist I
Syneos Health. Assist with safety, pharmacovigilance, and regulatory activities .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in safety, pharmacovigilance, and regulatory activities, with a strong focus on data management, including data cleaning, validation, and adherence to regulatory guidelines such as GCP and GVP.
Highest-signal resume keywords
MedDRA CodingData ManagementData CleaningGood Clinical Practice (GCP)Good Pharmacovigilance Practice (GVP)
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 ValidationData MappingData EnrichmentXEVMPD Product DictionarySPOR/IDMP Data Cleansing
Industry Keywords
PharmacovigilanceRegulatory ActivitiesData Privacy GuidelinesClinical TrialsPost-Marketing Safety Programs
About the role
Key responsibilities & impact- Assist with safety, pharmacovigilance, and regulatory activities
- Perform Medical Dictionary for Regulatory Activities (MedDRA) coding
- Conduct data management activities, including data cleaning and validation
- Perform xEVMPD product dictionary, SPOR/IDMP data cleansing, data mapping, data enrichment, and data validation
- Process information through filtering, cleansing, migrating, analyzing, reporting, filing, or publication of data
- Adhere to data privacy guidelines, GCP, GVP, regulatory guidelines, and company/project-specific procedures for clinical trials and/or post-marketing safety programs
Requirements
What you’ll need- Experience/skills and/or education equivalent to the qualifications described in the job description may be considered
- Adherence to data privacy guidelines, Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), regulatory guidelines, and company/project-specific procedures
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations when appropriate