Safety and PV Specialist Night Shift

The Safety and PV Specialist - Night Shift will support pharmacovigilance operations, ICSR case processing, adverse event documentation, safety database entry, quality review, and regulatory timelines during night shift operations at Syneos Health, Gurugram. This requires 2–6 years of experience in pharmacovigilance, ICSR processing, and drug safety workflows.

Roles & Responsibilities

• Process individual case safety reports during assigned night shift operations.
• Review source documents, adverse event details, patient information, and reporter data.
• Perform case intake, data entry, coding, narrative writing, and quality checks.
• Ensure timely completion and submission of safety cases as per regulatory timelines.
• Perform follow-up for missing information and case clarification when required.
• Coordinate with safety physicians, medical reviewers, quality teams, and global PV teams.
• Maintain compliance with SOPs, PV guidelines, and client-specific requirements.
• Track pending cases, workflow status, case queries, and escalation items.
• Support reconciliation, duplicate checks, and safety database maintenance.
• Report critical safety issues or urgent cases to senior team members promptly.
• Participate in audits, quality checks, and process improvement activities.
• Maintain confidentiality of patient, reporter, and product safety data.
• Follow night shift handover and communication process accurately.
• Ensure reliable, accurate, and compliant pharmacovigilance support.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success through innovative clinical development, medical affairs, and commercial solutions. Headquartered in Morrisville, North Carolina, USA, the company partners with pharmaceutical, biotechnology, and medical device organizations to bring life-changing therapies to patients faster and more efficiently.

With a global workforce of more than 26,000 professionals across over 110 countries, Syneos Health combines deep scientific expertise, advanced technologies, and market insights to help customers navigate the complexities of drug development and commercialization. The organization has established itself as one of the world's leading contract research and biopharmaceutical services companies.

Our Vision

Accelerating the impact of life-changing therapies worldwide. Through collaboration, innovation, and scientific excellence, Syneos Health strives to improve patient outcomes and transform healthcare globally.

Our Purpose

Driven to Deliver

At Syneos Health, every team member is united by a common purpose—to contribute to innovations that have the potential to improve and save lives. The organization believes in creating real-world impact by helping customers bring new therapies to patients with greater speed and confidence.

Core Service Areas

Syneos Health offers comprehensive solutions across the biopharmaceutical value chain, including:

• Clinical Development Services
• Phase I-IV Clinical Trials
• Medical Affairs Solutions
• Regulatory and Scientific Consulting
• Commercialization and Market Access
• Real-World Evidence and Data Analytics
• Pharmacovigilance Services
• Sales and Marketing Solutions
• Communications and Consulting Services
• AI-Driven Clinical and Commercial Solutions

These integrated capabilities enable customers to accelerate development timelines and maximize the value of their therapies.

Therapeutic Expertise

Syneos Health possesses extensive expertise across multiple therapeutic areas, including:

• Oncology and Hematology
• Central Nervous System Disorders
• Cardiovascular Diseases
• Infectious Diseases
• Rare Diseases
• Immunology
• Respiratory Medicine
• Metabolic Disorders
• Vaccines and General Medicine

The company has supported the development or commercialization of a significant percentage of novel drugs approved by regulatory authorities in recent years.

Global Reach

Operating across six continents, Syneos Health supports customers worldwide through its broad network of professionals, physicians, scientists, and operational experts. The company's collaborative approach helps biopharmaceutical organizations navigate evolving market demands and deliver innovative treatments to patients faster.

Core Values

Syneos Health is guided by principles that emphasize:

• Customer Focus
• Integrity and Transparency
• Collaboration and Teamwork
• Innovation and Agility
• Scientific Excellence
• Diversity, Equity, and Inclusion
• Accountability and Quality

These values drive the organization's commitment to delivering exceptional results and fostering long-term partnerships.

Why Choose Syneos Health?

• Leading global biopharmaceutical solutions organization
• Presence in more than 110 countries
• 26,000+ employees worldwide
• Integrated clinical and commercial expertise
• Advanced AI-driven capabilities
• Deep therapeutic and scientific knowledge
• Strong commitment to innovation and patient outcomes
• Trusted partner for pharmaceutical and biotechnology companies

Our Commitment

At Syneos Health, we believe that every innovation has the power to change lives. Through scientific excellence, operational expertise, and collaborative partnerships, we are committed to accelerating the development and delivery of life-changing therapies that improve health and transform the future of medicine.