Syneos PV Specialist I&II Pharmacovigilance Jobs
- Syneos Health Hiring Safety & PV Specialist II | Pharmacovigilance Jobs in Pune, Hyderabad & Gurugram (Night Shift)
- Company Overview
- Job Role & Responsibilities
- Eligibility / Qualifications
- Location & Salary
- Application Process
- Frequently Asked Questions (FAQs)
- Summary Table
Syneos Health Hiring Safety & PV Specialist II | Pharmacovigilance Jobs in Pune, Hyderabad & Gurugram (Night Shift)
Syneos Health is actively hiring for Safety & PV Specialist II roles under its Clinical Solutions and Pharmacovigilance department. This is a full-time opportunity for experienced professionals with a minimum of 4 years of pharmacovigilance experience. Openings are available across Pune, Hyderabad, and Gurugram locations, offering a strong career path in drug safety operations, regulatory compliance, and global clinical research services.
Company Overview
Syneos Health is a globally recognized, fully integrated biopharmaceutical solutions organization that supports pharmaceutical, biotechnology, and medical device companies across the entire drug development lifecycle. The company plays a critical role in accelerating clinical trials, regulatory approvals, and commercialization strategies.
With experience contributing to a majority of FDA-approved drugs and EMA-authorized products, Syneos Health has established itself as a trusted partner in clinical research and pharmacovigilance services. The organization combines deep therapeutic expertise with advanced clinical and safety data capabilities, making it a preferred employer for professionals in drug safety, clinical operations, and regulatory affairs.
Job Role & Responsibilities
As a Safety & PV Specialist II, you will be responsible for managing pharmacovigilance case processing, ensuring compliance with global safety regulations, and maintaining high-quality safety data.
- Process Individual Case Safety Reports (ICSRs) in compliance with SOPs and regulatory requirements
- Perform data entry, coding (MedDRA), and validation in safety databases
- Conduct case triage and assess reportability of adverse events
- Prepare narrative summaries and ensure completeness and accuracy of case data
- Handle duplicate case identification and resolution
- Perform literature screening and safety signal identification
- Support expedited reporting for regulatory submissions
- Maintain drug safety tracking systems and documentation
- Ensure compliance with GCP, ICH, GVP, and global pharmacovigilance guidelines
- Support audits, inspections, and quality review of safety data
- Contribute to Trial Master File (TMF) and Pharmacovigilance System Master File documentation
- Participate in SPOR/IDMP activities and xEVMPD submissions
This role provides strong exposure to global pharmacovigilance systems, regulatory compliance frameworks, and advanced drug safety analytics.
Eligibility / Qualifications
Candidates must meet the following criteria:
- B.Pharmacy, M.Pharmacy, BDS, BMS, or MBBS (Life Sciences graduates like BSc/MSc are not eligible)
- Minimum 4 years of experience in pharmacovigilance or drug safety roles
Relevant courses include: B.Pharmacy, M.Pharmacy, Pharm.D, MBBS, BDS, BMS
Key skills required:
- Strong knowledge of ICSR processing and pharmacovigilance workflows
- Expertise in MedDRA coding and safety database systems
- Understanding of global regulatory requirements (FDA, EMA, ICH, GVP)
- Experience in literature review and signal detection
- Attention to detail and data accuracy in safety reporting
- Ability to work in night shifts and global team environments
Location & Salary
- Locations: Pune, Hyderabad, Gurugram (Office-based)
- Work Mode: On-site (Night Shift)
- Salary: Competitive and aligned with industry standards for pharmacovigilance roles
Application Process
Interested candidates can apply directly through the official Syneos Health careers portal:
Ensure your resume highlights your pharmacovigilance experience, ICSR processing expertise, and regulatory knowledge to improve your chances of selection.
Frequently Asked Questions (FAQs)
1. What is the experience required for this role?
Candidates must have at least 4 years of pharmacovigilance experience.
2. Is this a night shift role?
Yes, candidates must be comfortable working in night shifts.
3. What qualifications are accepted?
B.Pharm, M.Pharm, BDS, BMS, or MBBS candidates are eligible.
4. What is the main responsibility of this role?
The role focuses on ICSR processing, safety data management, and regulatory compliance.
5. Where are the job locations?
Pune, Hyderabad, and Gurugram.
Summary Table
| Company | Syneos Health |
|---|---|
| Vacancies | Safety & PV Specialist II |
| Required Education | B.Pharmacy, M.Pharmacy, Pharm.D, MBBS, BDS, BMS |
| Experience | Minimum 4 Years |
To apply for this job please visit syneoshealth.wd12.myworkdayjobs.com.
