Syneos Health Recruiting Safety & Pharmacovigilance Coordinator
- Syneos Health Safety & Pharmacovigilance Coordinator Jobs in Gurgaon – B.Pharm / PharmD Drug Safety Careers
- Company Overview
- Job Role and Responsibilities
- Pharmacovigilance Case Processing
- Safety Documentation and Data Handling
- Safety Data Entry and Database Management
- Case Processing Support Activities
- Compliance and Quality Assurance
- Eligibility and Qualifications
- Educational Qualification
- Experience
- Technical Skills
- Professional Skills
- Location and Salary
- Application Process
- Frequently Asked Questions
- What does a Pharmacovigilance Coordinator do?
- Who can apply for this Syneos Health role?
- What is ICSR in pharmacovigilance?
- Is clinical trial safety experience required?
- Where is the job located?
- Job Summary
Syneos Health Safety & Pharmacovigilance Coordinator Jobs in Gurgaon – B.Pharm / PharmD Drug Safety Careers
Syneos Health is currently hiring Safety & Pharmacovigilance Coordinator professionals for its drug safety and pharmacovigilance operations team in Gurgaon, Haryana, India. This opportunity is ideal for healthcare graduates such as B.Pharm, M.Pharm, PharmD, or BDS who have at least 1 year of experience in pharmacovigilance, clinical trial safety data entry, or literature case processing.
The position focuses on Individual Case Safety Report (ICSR) processing, pharmacovigilance data entry, clinical trial safety documentation, and regulatory safety support within global drug development programs. Candidates with experience in clinical trial safety cases, literature safety cases, and safety database management will find this role highly aligned with career growth in the clinical research and pharmaceutical drug safety industry.
This full‑time role is based on‑site in Gurgaon, Haryana, and offers the opportunity to work with global clinical development teams supporting pharmaceutical sponsors and regulatory safety operations worldwide.
Company Overview
Syneos Health is a leading fully integrated biopharmaceutical solutions organization that helps pharmaceutical, biotechnology, and healthcare companies accelerate the development and commercialization of innovative therapies. The company combines clinical development, medical affairs, and commercial capabilities to support the entire lifecycle of medicines.
Operating across 110 countries with more than 29,000 employees, Syneos Health plays a major role in global drug development and clinical research operations. Over the past several years, the company has contributed to 94% of all FDA‑approved novel medicines and 95% of EMA‑authorized products, demonstrating its strong presence in the pharmaceutical research ecosystem.
The organization’s clinical development model focuses on placing both the patient and the sponsor at the center of drug development, ensuring faster, efficient delivery of life‑saving treatments. Employees working at Syneos Health benefit from a collaborative environment that emphasizes professional growth, technical training, and global exposure in clinical research and pharmacovigilance.
Job Role and Responsibilities
The Safety & Pharmacovigilance Coordinator supports global pharmacovigilance operations by assisting with the collection, processing, and documentation of safety information related to pharmaceutical products. The role focuses heavily on accurate data handling, case tracking, and compliance with global safety regulations.
Pharmacovigilance Case Processing
• Monitor incoming safety information from multiple sources and route it to appropriate project teams
• Assist with the preparation and processing of Individual Case Safety Reports (ICSRs)
• Perform accurate data entry of safety cases into pharmacovigilance databases
• Maintain proper documentation of safety cases in accordance with sponsor requirements
• Track safety cases and maintain case logs according to project guidelines
Safety Documentation and Data Handling
• Record and maintain ICSR documentation within safety tracking systems
• Redact patient‑identifying information from safety documents to comply with data protection guidelines
• Ensure compliance with ICH‑GCP, GVP, and regulatory pharmacovigilance standards
• Create and maintain case files in both electronic and paper formats
• Maintain accurate documentation for audit and inspection readiness
Safety Data Entry and Database Management
• Perform timely and accurate data entry into pharmacovigilance safety databases
• Maintain case tracking and workflow systems for safety reports
• Assist in daily workflow reconciliation activities
• Ensure safety data is captured according to client‑specific and internal SOP requirements
Case Processing Support Activities
• Support query follow‑up activities for incomplete or missing case information
• Assist in safety submission processes where required
• Coordinate translation of source documents when necessary
• Support pharmacovigilance teams in processing literature and clinical trial safety cases
Compliance and Quality Assurance
• Maintain working knowledge of Standard Operating Procedures (SOPs) and Work Instructions (WIs)
• Follow global pharmacovigilance regulations and drug safety guidelines
• Maintain awareness of ICH guidelines, GCP standards, and GVP modules
• Ensure compliance with project‑specific safety management plans and regulatory requirements
Through these responsibilities, the Safety & Pharmacovigilance Coordinator contributes to accurate drug safety monitoring and regulatory compliance during clinical trials and post‑marketing surveillance.
Eligibility and Qualifications
Candidates applying for the Safety & Pharmacovigilance Coordinator role should have educational backgrounds in healthcare or pharmaceutical sciences along with experience in pharmacovigilance operations.
Educational Qualification
Healthcare professional degree in relevant disciplines.
Relevant education backgrounds include:
B.Pharm, M.Pharm, PharmD, BDS, Pharmacy, Pharmaceutical Sciences, Clinical Pharmacy, Pharmacology.
Experience
• Minimum 1 year of experience in pharmacovigilance case processing or safety data entry
• Experience working with clinical trial (CT) safety cases or literature safety cases is preferred
Technical Skills
• Knowledge of pharmacovigilance safety databases and drug safety workflows
• Understanding of medical terminology and adverse event reporting
• Familiarity with ICH‑GCP guidelines and pharmacovigilance regulations
• Experience processing ICSR safety reports
• Proficiency in Microsoft Office tools including Word, Excel, and PowerPoint
• Familiarity with document management systems such as TeamShare or similar tools
Professional Skills
• Strong attention to detail and data accuracy
• Excellent written and verbal communication skills
• Strong organizational and documentation capabilities
• Ability to manage multiple tasks in a fast‑paced clinical research environment
• Ability to collaborate effectively with global pharmacovigilance teams
• Flexibility to work in rotational shifts when required
Professionals with experience in drug safety case processing, pharmacovigilance data entry, and clinical trial safety documentation will find this role well aligned with long‑term careers in global CRO organizations.
Location and Salary
Location: Gurgaon, Haryana, India
Work Model: On‑site
Work Type: Full‑time role within global pharmacovigilance operations
Application Process
Candidates interested in applying for the Safety & Pharmacovigilance Coordinator role can submit their applications through the official Syneos Health careers portal.
Apply Here:
Applicants are encouraged to apply early since pharmacovigilance roles within global CRO organizations typically receive high application volumes.
Frequently Asked Questions
What does a Pharmacovigilance Coordinator do?
A Pharmacovigilance Coordinator assists with processing safety cases, managing pharmacovigilance databases, documenting adverse events, and supporting regulatory drug safety reporting during clinical trials and post‑marketing monitoring.
Who can apply for this Syneos Health role?
Candidates with healthcare degrees such as B.Pharm, M.Pharm, PharmD, or BDS with at least one year of pharmacovigilance or safety data entry experience can apply.
What is ICSR in pharmacovigilance?
ICSR stands for Individual Case Safety Report. It is a detailed report that documents adverse events associated with pharmaceutical products during clinical trials or post‑marketing monitoring.
Is clinical trial safety experience required?
Yes. Experience working with clinical trial safety cases or literature safety cases is preferred for this role.
Where is the job located?
The role is located in Gurgaon, Haryana, India, within Syneos Health’s pharmacovigilance operations team.
Job Summary
| Category | Details |
|---|---|
| Company | Syneos Health |
| Vacancies | Safety & Pharmacovigilance Coordinator |
| Required Education | B.Pharm, M.Pharm, PharmD, BDS, Pharmacy, Pharmaceutical Sciences, Pharmacology |
| Experience | Minimum 1 year Pharmacovigilance / Safety Data Entry |
To apply for this job please visit syneoshealth.wd12.myworkdayjobs.com.
