Location: Gurugram / Hyderabad, India (Hybrid)
Company: Syneos Health
Job Type: Full-Time
Job Requisition ID: 25106996
Experience Required: Minimum 6 Years Experience in Safety & Pharmacovigilance
Freshers Eligible: No
About the Company
Syneos Health is a globally recognized, integrated biopharmaceutical and clinical research organization dedicated to accelerating customer success across the drug development and commercialization lifecycle. The company partners with leading pharmaceutical, biotechnology, and healthcare innovators worldwide to advance patient-focused healthcare solutions.
Job Overview
Syneos Health is hiring experienced professionals for the role of Senior Safety & Pharmacovigilance Submission Specialist in Gurugram and Hyderabad. This role is ideal for candidates with strong expertise in pharmacovigilance operations, regulatory safety submissions, safety reporting compliance, and global PV guidelines.
The selected candidate will collaborate with sponsors, regulatory teams, and project stakeholders to manage expedited and periodic safety submissions while ensuring compliance with global pharmacovigilance regulations including FDA, EMA, ICH-GCP, GVP, and Indian regulatory guidelines.
Key Responsibilities
Collaborate with sponsors and internal project management teams for preparation, assembly, and submission of expedited and periodic safety reports
Participate in project launch activities related to pharmacovigilance safety reporting
Develop and maintain Safety Reporting Plans for assigned projects
Track safety submissions and maintain accurate regulatory documentation
Provide sponsors and clients with regular safety submission status updates
Support teams with safety reporting regulatory guidance and issue resolution
Apply global regulatory intelligence to all pharmacovigilance submission activities
Ensure proper filing and maintenance of documents within Trial Master File (TMF) systems
Coordinate submission of completed safety documents to clients, regulatory authorities, ethics committees, and relevant stakeholders
Serve as a key point of contact for safety submission-related regulatory matters
Assist in workload distribution and team coordination activities
Participate in internal audits, project review meetings, and compliance assessments
Monitor KPIs, cycle time metrics, and project timelines for submission activities
Ensure adherence to SOPs, Work Instructions, ICH-GCP, GVP, and international pharmacovigilance regulations
Required Qualifications
Bachelor’s Degree in Life Sciences, Pharmacy, Nursing, or related healthcare discipline
Minimum 6 years of experience in Safety and Pharmacovigilance operations
Prior experience in safety submissions to regulatory authorities, ethics committees, and clinical trial sites
Strong understanding of global PV regulations including FDA, EMA, EMEA, ICH-GCP, GVP, and Indian pharmacovigilance guidelines
Experience handling safety databases and medical terminology
Knowledge of clinical trial processes across Phase II–IV studies and post-marketing safety activities
Experience leading pharmacovigilance or safety submission projects preferred
Hands-on experience with TMF filing and oversight activities
Proficiency in Microsoft Office Suite, Outlook, Visio, and collaborative workspace platforms
Excellent communication, organizational, and project management skills
Ability to work independently and within cross-functional global teams
Preferred Skills
Strong analytical and regulatory interpretation capabilities
High attention to detail and accuracy in safety documentation
Ability to manage multiple projects under strict timelines
Effective stakeholder communication and presentation skills
Experience working in CRO or global clinical research environments preferred
Why Join Syneos Health?
Opportunity to work with one of the world’s leading clinical research and life sciences organizations
Exposure to global pharmacovigilance and regulatory operations
Career growth opportunities within international drug safety and clinical research domains
Collaborative and innovation-driven work culture
Participation in high-impact global clinical development programs
Over the past five years, Syneos Health has contributed to:
94% of Novel FDA Approved Drugs
95% of EMA Authorized Products
200+ global clinical studies
73,000+ clinical trial sites worldwide
675,000+ clinical trial patients
Important Note for Applicants
This is a senior-level pharmacovigilance role and is not suitable for freshers. Candidates applying for this position should have strong hands-on experience in safety reporting, regulatory submissions, and global pharmacovigilance operations.
How to Apply
Interested candidates can apply through the official careers portal of Syneos Health or explore more verified global Pharmacovigilance, Drug Safety, Clinical Research, Regulatory Affairs, and Medical Writing jobs at ThePharmaDaily.com.
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