Safety & PV Specialist I

Syneos Health

. Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required .

Posted 9/15/2026full-timeRemote • BrazilMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Pharmacovigilance and Safety Reporting, with a strong understanding of regulatory requirements and clinical trial processes. Proficient in data management, coding, and maintaining compliance with industry standards.

Highest-signal resume keywords

PharmacovigilanceSafety Database SystemsICH GCPMedDRA CodingClinical Trial Process

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data EntryICSR ProcessingEvent CodingNarrative SummarizationLiterature ScreeningQuality ReviewRegulatory Report GenerationDrug Dictionary MaintenanceSPOR / IDMP ActivitiesDuplicate ICSR Management

Soft Skills

Excellent CommunicationInterpersonal SkillsOrganizational SkillsDetail OrientedAbility to Work Independently

Tools & Technologies

Microsoft Office SuiteVisioOutlookTeam ShareSafety Tracking Systems

Industry Keywords

GVPGlobal Drug RegulationsSOPsWIsDrug Development Process

About the role

Key responsibilities & impact

Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required
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 in accordance with regulatory requirements
Maintain safety tracking for assigned activities
Perform literature screening and review for safety, drug coding, drug dictionary maintenance, and 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, global drug/biologic/device 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 that gives the individual the necessary knowledge, skills, and abilities to perform the job
Safety Database systems and knowledge of medical terminology required
Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet
Ability to work independently and in a team environment
Excellent communication and interpersonal skills, both written and spoken
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
Total rewards program
Inclusive culture
Reasonable accommodations when appropriate