Safety & Pharmacovigilance (PV) Coordinator
Location: Hyderabad, India
Job ID: 25103054
Employment Type: Full-Time
Experience Required: 2–5 years (preferred in Pharmacovigilance or Clinical Safety)
Functional Area: Drug Safety / Pharmacovigilance / Clinical Development
About the Organization
Syneos Health® is a globally recognized, fully integrated biopharmaceutical solutions organization focused on accelerating customer success across clinical development, medical affairs, and commercialization. Operating in over 110 countries with a workforce of 29,000+ professionals, Syneos Health partners with pharmaceutical, biotechnology, and medical device companies to streamline drug development and deliver innovative therapies to patients worldwide.
The organization has contributed to the development of 94% of Novel FDA-Approved Drugs and 95% of EMA-Authorized Products over the past five years, supporting more than 200 studies across 73,000+ sites and 675,000+ clinical trial participants.
Role Overview
The Safety & PV Coordinator plays a critical role in supporting global pharmacovigilance and clinical safety operations. This position ensures compliance with regulatory standards while coordinating safety reporting activities across clinical trials and post-marketing surveillance programs.
The role requires strong expertise in drug safety case management, safety documentation, regulatory compliance, and cross-functional coordination within a clinical development environment.
Key Responsibilities
Pharmacovigilance & Safety Coordination
Support global pharmacovigilance (PV) operations and clinical safety activities
Coordinate processing and tracking of Individual Case Safety Reports (ICSRs)
Ensure accurate documentation and reporting of adverse events in compliance with global regulatory requirements
Maintain safety databases and support safety data reconciliation processes
Assist in safety reporting for clinical trials and post-marketing programs
Regulatory & Compliance Oversight
Ensure adherence to ICH-GCP, GVP, FDA, EMA, and other global pharmacovigilance guidelines
Support audit and inspection readiness activities
Maintain compliance with SOPs, client requirements, and applicable legislation
Contribute to safety documentation updates and quality control reviews
Cross-Functional Collaboration
Work closely with Clinical Operations, Regulatory Affairs, Medical Affairs, and Data Management teams
Support communication between sponsors, investigators, and internal stakeholders
Assist in process improvement initiatives to enhance pharmacovigilance efficiency
Education & Experience Requirements
Educational Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Medicine, Nursing, or related healthcare discipline
Advanced degree preferred but not mandatory
Professional Experience
2–5 years of experience in pharmacovigilance, drug safety, or clinical safety coordination
Experience in safety case processing, ICSR management, or clinical trial safety reporting preferred
Exposure to global regulatory frameworks (FDA, EMA, ICH guidelines) strongly preferred
Equivalent experience, skills, or education may be considered based on organizational criteria.
Required Skills & Competencies
Technical Skills
Knowledge of pharmacovigilance processes and safety reporting requirements
Familiarity with safety databases and case tracking systems
Understanding of adverse event reporting and signal detection processes
Awareness of global drug safety regulations and compliance standards
Professional Skills
Strong organizational and coordination abilities
High attention to detail and data accuracy
Effective written and verbal communication skills
Ability to work in a fast-paced, evolving clinical development environment
Proactive problem-solving and initiative-driven mindset
Work Environment & Culture
Syneos Health promotes a collaborative and performance-driven culture focused on innovation, inclusion, and professional growth. Employees benefit from:
Career development and structured progression pathways
Technical and therapeutic area training
Supportive leadership and performance recognition programs
Inclusive, diversity-driven global workplace
Important Information
Responsibilities listed are not exhaustive and may evolve based on business needs.
The organization complies with global employment legislation, including equality directives and disability accommodation standards.
This job description does not constitute an employment contract.
Why Apply Through ThePharmaDaily?
Access high-impact global pharmacovigilance and clinical safety roles
Connect with leading biopharmaceutical and CRO organizations
Advance your career in drug safety and regulatory compliance
Gain international exposure within clinical development programs
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