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Safety & Pv Coordinator

0-2 years
Not Disclosed
10 Oct. 1, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Safety & PV Coordinator

Location: Gurugram, India
Job ID: 25101792
Company: Syneos Health®
Status: This job posting is no longer active (for talent pipeline consideration)
Updated: Yesterday


About Syneos Health

Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization built to accelerate customer success. The company integrates clinical, medical affairs, and commercial insights to deliver efficient outcomes that address modern healthcare challenges.

With a presence in over 110 countries and 29,000 employees, Syneos Health focuses on innovation, agility, and patient-centric approaches.

Why Syneos Health

  • Career development and progression opportunities

  • Supportive and engaged line management

  • Technical and therapeutic area training

  • Peer recognition and total rewards program

  • Inclusive Total Self culture promoting authenticity and diversity

Work Here Matters Everywhere.


Job Overview

The Safety & PV Coordinator supports Pharmacovigilance (PV) operations, ensuring compliance with global regulatory requirements and company standards. The role involves managing case intake, documentation, safety database entry, and assisting with various safety reporting activities.


Key Responsibilities

Case Processing & Documentation

  • Monitor and route incoming safety information to appropriate projects

  • Record and track ICSR (Individual Case Safety Report) documentation

  • Redact patient identifiers/images per data protection, ICH GCP, and GVP guidelines

  • Enter data into safety databases per sponsor/customer guidelines

  • Maintain accuracy and consistency in case entry and conventions

Administrative & Workflow Management

  • Create, maintain, and track files (paper/electronic)

  • Manage document translation processes

  • Support query follow-ups and submissions

  • Assist in daily workflow reconciliation

Safety & Literature Activities

  • Support literature screening and safety review

  • Maintain drug dictionary and perform MedDRA coding

  • Assist in narrative writing and event/medication/test coding

  • Generate accurate expedited safety reports per regulatory timelines

Regulatory & Database Activities

  • Validate xEVMPD product records and indication coding

  • Handle duplicate ICSR identification and resolution

  • Perform manual recoding of product/substance terms if needed

  • Support SPOR / IDMP-related activities

Compliance & Quality

  • Ensure documents are filed in TMF and PV System Master File

  • Follow SOPs, WIs, GCP, ICH, and GVP guidelines

  • Apply safety reporting regulatory intelligence to daily tasks

  • Participate in audits when required

Team Collaboration

  • Foster professional relationships within project teams

  • Work cross-functionally with internal/external stakeholders


Qualifications

Education

  • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or equivalent

Experience

  • Prior experience in safety database systems preferred

  • Familiarity with medical terminology

Skills

  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Visio)

  • Strong communication (written & verbal) and interpersonal skills

  • Detail-oriented with high accuracy

  • Excellent organization and documentation skills

  • Ability to multitask and prioritize effectively

  • Team player with collaborative mindset


Additional Information

  • This posting is for an upcoming opportunity (Talent Pipeline)

  • Equivalent experience, skills, or education may be considered

  • Committed to Equal Employment Opportunity and Americans with Disabilities Act compliance


About Syneos Health (Key Highlights)

  • Partnered on 94% of all FDA Novel Drug Approvals (past 5 years)

  • Supported 95% of EMA Authorized Products

  • Managed 200+ studies across 73,000 sites and 675,000+ trial patients

Website: www.syneoshealth.com


Job Category: Safety & Pharmacovigilance (Clinical Operations)