Pharmacovigilance Job at Syneos Health | Apply Now
Looking for a pharmacovigilance job in a global biopharmaceutical company? Syneos Health is hiring a Safety & PV Specialist I – Medical Device & Product Quality in Hyderabad and Gurugram, India. This is a full-time opportunity for experienced professionals in drug safety, product quality complaint handling, and regulatory reporting. If you are searching for BDS jobs, MBBS jobs, or exploring Syneos Health careers, this role offers strong career growth in pharmacovigilance and clinical safety.
Job Details:
- Job Position: Safety & Pharmacovigilance Specialist I – Medical Device & Product Quality
- Location: Hyderabad / Gurugram, India
- Experience Required: 2.5 – 4 Years
About the Company:
Syneos Health is a leading, fully integrated biopharmaceutical solutions organization built to accelerate customer success. The company translates unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Its Clinical Development model brings the customer and the patient to the center of everything that they do. Syneos Health is continuously looking for ways to simplify and streamline work to not only make Syneos Health easier to work with, but to make it easier to work for. With 29,000 employees across 110 countries, Syneos Health has worked with 94% of all Novel FDA-approved drugs, 95% of EMA-authorized products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
Job Description:
The Safety & Pharmacovigilance Specialist I is responsible for end-to-end ICSR processing, quality review, regulatory reporting support, and compliance activities. The role requires demonstrated expertise in Product Quality Complaint case handling and medical research safety cases. This pharmacovigilance job is ideal for candidates seeking advanced roles in global safety reporting and compliance.
Qualifications:
- Education: BDS / MBBS
- Minimum 1 year of experience handling Product Quality Complaint (PQC) cases exclusively.
- Experience in handling medical research safety cases.
- Hands-on experience in Argus / ARISg safety database.
- Strong understanding of global pharmacovigilance regulations.
- Experience in clinical trials and/or post-marketing safety reporting.
Key Responsibilities:
- Perform end-to-end ICSR processing and quality review.
- Conduct medical coding (events, medical history, concomitant medications, laboratory data).
- Prepare comprehensive narratives and manage follow-up queries.
- Identify and manage duplicate ICSRs.
- Support xEVMPD validation and submission activities.
- Contribute to SPOR / IDMP-related activities.
- Maintain safety tracking and ensure timely regulatory submissions.
- Support audit readiness and regulatory inspections.
- Ensure adherence to SOPs, GVP, ICH-GCP, and global safety regulations.
