Safety and PV Coordinator
Company: Syneos Health
Location: Hyderabad, Telangana, India
Work Mode: Not Specified
Employment Type: Full-Time
Job Overview
The Safety and PV Coordinator supports pharmacovigilance and drug safety operations by ensuring compliance with global regulatory requirements, maintaining safety documentation, coordinating safety activities, and supporting project teams across clinical development and post-marketing programs. This role requires strong organizational, communication, and compliance management skills within a pharmaceutical, biotechnology, or CRO environment.
Key Responsibilities
Support pharmacovigilance and drug safety activities across assigned projects.
Coordinate safety documentation, tracking, and reporting activities.
Maintain accurate safety records and ensure compliance with company SOPs and regulatory requirements.
Assist project teams in managing safety deliverables and timelines.
Support preparation and maintenance of Pharmacovigilance System Master File (PSMF) documentation where applicable.
Coordinate with internal and external stakeholders regarding safety-related activities.
Ensure proper filing and maintenance of safety documents and records.
Assist in audit and inspection readiness activities.
Monitor compliance with global pharmacovigilance regulations, GCP, ICH guidelines, and company procedures.
Support continuous improvement initiatives within safety and pharmacovigilance operations.
Required Qualifications
Bachelor’s Degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Healthcare, or a related discipline.
Understanding of pharmacovigilance and drug safety processes.
Knowledge of ICH-GCP guidelines and global pharmacovigilance regulations.
Strong documentation and coordination skills.
Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
Preferred Qualifications
Prior experience within a CRO, pharmaceutical, or biotechnology company.
Exposure to safety databases and pharmacovigilance systems.
Experience supporting audits, inspections, or compliance activities.
Familiarity with safety reporting requirements and regulatory submissions.
Knowledge of PSMF management and PV quality systems.
Experience Required
1–4 years of experience in Pharmacovigilance, Drug Safety, Clinical Safety Operations, Regulatory Safety, or related healthcare/pharmaceutical functions.
Experience in a CRO or pharmaceutical industry environment will be preferred.
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