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Status: This job posting is no longer active (for talent pipeline consideration)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)
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