Safety & Pharmacovigilance Coordinator (PV Submission) – Gurgaon | Syneos Health
Updated: December 5, 2025
Location: Gurugram, India
Job ID: 25104098
Role Type: Office-based | Full-time
Syneos Health is a global, fully integrated biopharmaceutical solutions organization committed to accelerating clinical and commercial success for its partners worldwide. With teams operating across 110 countries, the organization brings together clinical development, medical affairs, and commercial expertise to deliver high-impact, patient-centered outcomes.
This position offers an opportunity to contribute directly to global pharmacovigilance operations, supporting regulatory safety submissions and ensuring compliance with international drug safety standards.
Position Overview
The Safety & PV Coordinator will support safety submission activities for expedited and periodic reports, maintain documentation, and ensure regulatory compliance aligned with global pharmacovigilance requirements. This office-based role requires strong coordination skills, attention to detail, and an understanding of PV submission processes.
Key Responsibilities
Maintain and update safety submission tracking systems.
Build and maintain professional working relationships with internal and external project stakeholders.
Apply current regulatory intelligence related to safety reporting across all relevant activities.
Organize and file project-specific documents electronically or in hard copy, as per requirements.
Assist in the preparation, formatting, and assembly of expedited and periodic safety report packages.
Support diverse project tasks related to safety submissions, including quality checks and documentation flow.
Forward completed safety submission documents to clients, regulatory authorities, ethics committees, and other designated recipients.
Ensure full compliance with Standard Operating Procedures (SOPs), Work Instructions (WIs), global safety regulations, GCP, ICH, and GVP guidelines.
Contribute to efficient safety reporting processes within the drug development lifecycle.
Required Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or an equivalent field.
Foundational understanding of global pharmacovigilance regulations, including ICH and GVP.
Familiarity with safety submissions, expedited and periodic reporting, and regulatory requirements.
Knowledge of eTMF filing procedures and documentation standards.
Strong organizational and communication skills with the ability to prioritize tasks effectively.
Proficiency in Microsoft Office applications and document management systems.
Ability to work independently in a structured, compliance-driven environment.
Experience Required
1 to 3 years of experience in Pharmacovigilance, Drug Safety Operations, PV Submissions, or Safety Documentation Management.
Experience in safety submissions to regulatory authorities or ethics committees is preferred.
Exposure to clinical trial safety reporting or post-marketing PV is an advantage.
About Syneos Health
Over the last five years, Syneos Health has collaborated on:
94% of all Novel FDA-approved drugs
95% of EMA-authorized products
200+ global clinical studies across 73,000 sites and over 675,000 trial patients
Employees at Syneos Health work in a fast-evolving, competitive environment where innovation and continuous improvement are integral to success.
Learn more at: syneoshealth.com
Additional Information
This job description outlines key responsibilities but is not exhaustive. Syneos Health may assign additional duties based on business needs. Equivalent skills or experience may be considered in place of formal qualifications. The company is committed to equal opportunity employment and compliance with global regulatory requirements, including reasonable accommodations where applicable.
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