Syneos Health Hiring Safety & Pharmacovigilance Specialist I | QC experience
- Company Overview
- Job Role & Responsibilities
- Eligibility / Qualifications
- Educational Background
- Experience Requirements
- Technical & Professional Skills
- Location & Salary
- Application Process
- Frequently Asked Questions (FAQs)
Hiring Safety & PV Specialist with life science qualification. 1 vacancy in Gurgaon. Pharmacovigilance, QC, clinical safety role.
Syneos Health is hiring a Safety & Pharmacovigilance Specialist I with Quality Control experience for its on-site team in Gurgaon. This role sits at the intersection of clinical research, drug safety, and regulatory compliance, supporting global clinical trials and post-marketing safety activities. If you have hands-on experience in pharmacovigilance case processing and QC review, this position offers exposure to global safety systems, regulated markets, and complex drug development programs.
Company Overview
Syneos Health is a globally recognized, fully integrated biopharmaceutical solutions organization supporting pharmaceutical, biotechnology, and medical device companies across the entire product lifecycle. With operations spanning more than 110 countries and a workforce of over 29,000 professionals, Syneos Health plays a critical role in clinical development, medical affairs, and commercial execution.
The organization has contributed to the development of the majority of novel FDA-approved and EMA-authorized products in recent years. Its operating model places patients and sponsors at the center, combining clinical, safety, and regulatory expertise to accelerate access to safe and effective therapies worldwide.
Job Role & Responsibilities
As a Safety & PV Specialist I (QC Experience), you will support pharmacovigilance operations across clinical trial and post-marketing programs. The role focuses on Individual Case Safety Report (ICSR) processing, quality control, regulatory compliance, and safety database management.
Key responsibilities include:
- Processing and quality review of ICSRs in accordance with global SOPs, work instructions, and project-specific safety plans
- Triage and evaluation of safety cases for completeness, accuracy, and regulatory reportability
- Data entry and maintenance of safety information within validated pharmacovigilance databases
- Medical coding of adverse events, medical history, concomitant medications, and laboratory tests using MedDRA
- Preparation of high-quality narrative summaries and identification of follow-up queries
- Timely submission of expedited safety reports in line with global regulatory timelines
- Management of duplicate case identification and reconciliation
- Literature screening and safety surveillance activities
- Maintenance and validation of xEVMPD product records, including MedDRA coding of indications
- Execution of activities related to SPOR and IDMP requirements
- Quality control review of safety cases across clinical trial, spontaneous, and post-marketing sources
- Filing of safety documents in the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF)
- Participation in internal, sponsor, and regulatory audits
- Continuous application of safety regulatory intelligence to daily PV operations
Eligibility / Qualifications
Candidates should meet the following criteria:
Educational Background
Bachelor’s degree in life sciences, pharmacy, nursing, or an equivalent scientific discipline. Equivalent combinations of education and relevant experience may be considered.
Relevant courses include:
B.Pharm, M.Pharm, B.Sc Life Sciences, M.Sc Life Sciences, Clinical Research, Pharmacology, Nursing, Biotechnology
Experience Requirements
- Minimum 3 years of hands-on experience in pharmacovigilance case processing
- Demonstrated experience in quality control (QC) review of safety cases
- Exposure to clinical trial, post-marketing surveillance, and spontaneous adverse event reporting
- Practical knowledge of safety databases and medical terminology
Technical & Professional Skills
- Strong understanding of ICH GCP, GVP, and global safety regulations
- Knowledge of clinical trial processes across Phases II–IV
- Experience with safety reporting timelines and regulatory submissions
- Proficiency in Microsoft Office tools including Word, Excel, PowerPoint, and Outlook
- High attention to detail with strong organizational and time management skills
- Ability to work independently while collaborating effectively within cross-functional teams
- Clear written and verbal communication skills
Location & Salary
- Job Location: Gurgaon, Haryana (On-site)
- Employment Type: Full-time
- Salary: Competitive and aligned with industry standards (commensurate with experience)
Application Process
Interested candidates can apply online through the official Syneos Health careers portal using the link below:
Frequently Asked Questions (FAQs)
Is this role focused on clinical trials or post-marketing safety?
The role covers both clinical trial and post-marketing safety, including spontaneous case processing.
Is QC experience mandatory for this position?
Yes. Prior experience in QC review of pharmacovigilance cases is required.
Is this a work-from-home role?
No. This position is on-site in Gurgaon.
What safety databases are used?
Candidates with experience in leading safety databases and MedDRA coding are preferred.
Does Syneos Health provide career growth opportunities in PV?
Yes. Structured training, internal mobility, and exposure to global programs support long-term career development.
| Company | Syneos Health |
|---|---|
| Vacancies | 1 |
| Required Education | B.Pharm, M.Pharm, B.Sc/M.Sc Life Sciences, Nursing |
| Experience | Minimum 3 years in Pharmacovigilance with QC experience |
To apply for this job please visit syneoshealth.wd12.myworkdayjobs.com.
