Safety & PV Specialist I

Syneos Health

Safety & PV Specialist at Syneos Health conducting pharmacovigilance duties and data management for ICSR. Collaborating within a global team to ensure regulatory compliance and high-quality reporting.

Posted 7/2/2026full-timeHyderabad • 🇮🇳 IndiaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance processes, including ICSR processing, data entry, and regulatory compliance. Proficient in coding, quality review, and maintaining safety tracking systems in accordance with SOPs and regulatory guidelines.

Highest-signal resume keywords

ICSR ProcessingMedDRA CodingRegulatory ComplianceData EntryQuality Review

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data EntryICSR ProcessingMedDRA CodingSafety ReportingQuality ReviewLiterature ScreeningRegulatory ReportingDrug CodingEvent CodingDuplicate ICSR Management

Soft Skills

Professional Relationship BuildingCollaborationProblem Solving

Tools & Technologies

Safety DatabasePVG Quality SystemsTrial Master File (TMF)SPOR / IDMP

Industry Keywords

PharmacovigilanceGCPICH GuidelinesGVPSOPsWork InstructionsDrug Development Process

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.
Enters data into safety database.
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.
Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.
Manual recoding of un-recoded product and substance terms arises from ICSRs.
Identification and management of duplicate ICSRs.
Activities related to SPOR / IDMP.
Quality review of ICSRs.
Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.
Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.
Fosters constructive and professional working relationships with all project team members, internal and external.
Participates in audits as required/appropriate.
Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.

Requirements

What you’ll need

Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.

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.