Senior Safety & PV Specialist

Syneos Health

Sr Safety & PV Specialist processing ICSRs for Syneos Health. Engaging in quality checks and data validation for pharmacovigilance activities.

Posted 7/3/2026full-timeGurugram • 🇮🇳 IndiaSeniorWebsite

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

Education: B. Pharm / M. Pharm / BDS / BMS / MBBS.
Location: Gurugram-Hyderabad Office based.
ICSR case processing experience along with Quality Check (QC) Experience is mandatory.
Minimum 6 years of PV experience.

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.
Committed to building an inclusive culture – where you can authentically be yourself.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Data EntryEvent CodingMedical History CodingConcomitant Medications CodingLiterature ScreeningSafety ReportingRegulatory Report GenerationQuality ReviewDuplicate ICSR ManagementXEVMPD Product Record Validation

Soft Skills

Professional Relationship BuildingTeam CollaborationProblem Solving