Safety & PV Specialist I

Syneos Health

Safety & PV Specialist I process ICSR at Syneos Health, ensuring compliance with regulatory requirements and managing safety tracking systems.

Posted 7/3/2026full-timeRemote • 🇲🇽 MexicoMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance and safety reporting, with a strong understanding of clinical trial processes and regulatory requirements. Proficient in data entry, coding, and maintaining safety databases while ensuring accuracy and compliance.

Highest-signal resume keywords

PharmacovigilanceICSR ProcessingSafety Database SystemsMedical TerminologyRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data EntryICSR CodingMedDRA CodingLiterature ScreeningNarrative Summarization

Soft Skills

Excellent CommunicationInterpersonal SkillsOrganizational SkillsDetail OrientedAbility to Prioritize

Tools & Technologies

Microsoft Office SuiteVisioOutlookTeam Share

Industry Keywords

Clinical Trial ProcessICH GCPGVPSafety RequirementsPost-Marketing Safety

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.
Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required.
Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
Codes events, medical history, concomitant medications, and tests. Compiles complete narrative summaries.
Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
Maintains safety tracking for assigned activities.
Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.

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.
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

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to building an inclusive culture – where you can authentically be yourself.