Apply for Syneos Health Hiring for Safety / PV Specialist Gurugram. 2.5–4 years PV experience required.
Introduction
Syneos Health®, a leading global biopharmaceutical solutions company, is inviting applications for the position of Safety & Pharmacovigilance (PV) Specialist I. This opportunity is ideal for professionals with 2.5 to 4 years of experience in pharmacovigilance (PV) and ICSR case processing. Syneos Health Hiring for Safety / PV Specialist
The company, recognized for accelerating clinical and commercial success for clients worldwide, is seeking qualified professionals to join its Safety Operations team in Gurugram or Pune, India. If you hold a B.Pharm, M.Pharm, BDS, BMS, or MBBS degree and have hands-on experience in Argus or Aris-G database systems, this could be the perfect role to advance your PV career. Syneos Health Hiring for Safety / PV Specialist
About Syneos Health
Syneos Health is a fully integrated biopharmaceutical solutions organization that combines clinical development, medical affairs, and commercial capabilities under one global framework. With over 29,000 employees operating in more than 110 countries, the company collaborates with top pharmaceutical and biotechnology firms to deliver innovative solutions that improve patient outcomes. Syneos Health Hiring for Safety / PV Specialist
Syneos Health has contributed to 94% of all FDA-approved novel drugs and 95% of EMA-authorized products in the past five years. The company’s mission is centered on transforming healthcare through collaboration, innovation, and passion for improving lives. Syneos Health Hiring for Safety / PV Specialist
Position Overview: Safety & PV Specialist I
Job Title: Safety & PV Specialist I
Job Location: Gurugram or Pune, India
Job ID: 25103034
Experience Required: 2.5 – 4 years in Pharmacovigilance
Educational Qualification: B.Pharm / M.Pharm / BDS / BMS / MBBS
(Note: B.Sc / M.Sc candidates are not eligible)
Employment Type: Full-time
Tools Required: Argus Database / Aris-G
Department: Pharmacovigilance (PV) / Drug Safety
This position offers an opportunity to be part of a dynamic team focused on global safety reporting, ICSR processing, and regulatory compliance within a supportive, growth-oriented work environment. Syneos Health Hiring for Safety / PV Specialist
Key Responsibilities of Safety & PV Specialist I
As a Safety & Pharmacovigilance Specialist I, you will play a critical role in maintaining patient safety through accurate and timely case processing and reporting of adverse events. Syneos Health Hiring for Safety / PV Specialist
Below are the major responsibilities of the role:
1. Individual Case Safety Report (ICSR) Processing
- Perform data entry, triage, and booking of ICSRs into the safety database (Argus/Aris-G).
- Evaluate case data for completeness, accuracy, and regulatory reportability.
- Code medical terms, events, and concomitant medications using MedDRA and WHO-DD.
- Draft and finalize complete narrative summaries for cases.
- Identify missing information and follow up until queries are resolved.
2. Quality and Compliance
- Process ICSRs according to Standard Operating Procedures (SOPs), Work Instructions (WIs), and Safety Management Plans (SMPs).
- Maintain compliance with global pharmacovigilance guidelines such as GVP, ICH, and FDA regulations.
- Conduct quality review of processed cases to ensure accuracy before submission.
3. Literature Review and Drug Coding
- Perform literature screening and data extraction for potential adverse events.
- Maintain the drug dictionary and support MedDRA coding updates as per global standards.
- Validate and submit xEVMPD product records and ensure correct indication coding.
4. Documentation and Audit Readiness
- Ensure all relevant case documents are filed in the Trial Master File (TMF) for clinical studies and the Pharmacovigilance System Master File (PSMF) for post-marketing programs.
- Support internal and external audits and ensure data integrity in all submissions.
5. Communication and Collaboration
- Collaborate with clinical operations, regulatory, and quality assurance teams to ensure seamless safety data management.
- Maintain professional relationships with both internal stakeholders and external partners.
6. Continuous Improvement
- Participate in process improvement initiatives.
- Apply safety reporting intelligence and regulatory updates to enhance compliance standards.
- Contribute to maintaining up-to-date safety data systems and documentation processes.
Educational Qualification
Applicants must hold a recognized degree in any of the following fields:
- Bachelor of Pharmacy (B.Pharm)
- Master of Pharmacy (M.Pharm)
- Bachelor of Dental Surgery (BDS)
- Bachelor of Medical Science (BMS)
- Bachelor of Medicine and Bachelor of Surgery (MBBS)
Note: Candidates with B.Sc or M.Sc qualifications are not eligible for this position.
Experience and Skills Required
To be considered for the Safety & PV Specialist I role at Syneos Health, candidates should meet the following requirements: Syneos Health Hiring for Safety / PV Specialist
- Experience: 2.5 to 4 years of experience in pharmacovigilance, particularly ICSR case processing.
- Database Knowledge: Working experience with Argus or Aris-G safety databases.
- Technical Skills: Familiarity with MedDRA and WHO-DD coding standards.
- Regulatory Understanding: Knowledge of GVP, ICH, and global drug safety guidelines.
- Analytical Skills: Strong attention to detail with a focus on accuracy and regulatory timelines.
- Communication Skills: Excellent written and verbal communication in English.
- Teamwork: Ability to collaborate effectively in cross-functional, global teams.
Why Join Syneos Health?
Syneos Health is not just another CRO—it’s a global biopharmaceutical powerhouse that values innovation, teamwork, and employee growth. Joining the organization offers you the chance to work on global drug safety projects, improve healthcare outcomes, and enhance your expertise in pharmacovigilance. Syneos Health Hiring for Safety / PV Specialist
Employee Benefits:
- Career growth and structured progression path.
- Access to technical and therapeutic area training programs.
- Opportunity to work on FDA and EMA-regulated clinical studies.
- Inclusive work culture that celebrates diversity and authenticity.
- Comprehensive benefits package including health coverage and performance bonuses.
- Peer recognition and total rewards programs.
Syneos Health emphasizes its “Total Self Culture”, encouraging employees to bring their authentic selves to work. Diversity, equality, and inclusion are core values woven into every aspect of the organization.
Career Growth Path
Starting as a Safety & PV Specialist I, you can advance to higher levels of responsibility, such as:
- Safety Specialist II / Senior PV Associate
- Team Lead – Case Processing
- PV Scientist / Aggregate Reporting Specialist
- Safety Manager / Medical Reviewer
The company’s training and mentorship programs ensure a clear path for career progression within the global pharmacovigilance function. Syneos Health Hiring for Safety / PV Specialist
About Syneos Health’s Global Impact
Over the past five years, Syneos Health has collaborated on:
- 94% of all FDA-approved novel drugs,
- 95% of EMA-authorized products, and
- Managed 200+ clinical studies across 73,000 sites and 675,000+ trial patients globally.
This global experience makes Syneos Health an ideal workplace for professionals who want to contribute to the future of pharmaceutical innovation. Syneos Health Hiring for Safety / PV Specialist
How to Apply for Safety & PV Specialist I at Syneos Health
If you meet the eligibility criteria and have the required experience, follow the steps below to apply: Syneos Health Hiring for Safety / PV Specialist
Application Process
- Visit the official Syneos Health career portal:
👉 https://www.syneoshealth.com - Navigate to the Careers section and search for Job ID: 25103034 or the title “Safety & PV Specialist I – India”.
- Review the job description carefully.
- Click on Apply Now and create an account or log in.
- Fill in your details, upload your updated resume, and submit your application online.
Alternatively, if you are not ready to apply immediately, you can join the Syneos Health Talent Network to receive updates about future job openings in pharmacovigilance, clinical research, and medical affairs. Syneos Health Hiring for Safety / PV Specialist
Frequently Asked Questions (FAQs)
1. What is the minimum experience required for this role?
You need 2.5 to 4 years of experience in pharmacovigilance and ICSR case processing.
2. Which qualifications are eligible?
Candidates with B.Pharm, M.Pharm, BDS, BMS, or MBBS degrees are eligible. B.Sc and M.Sc are not accepted.
3. What tools are used in this position?
You must have hands-on experience with Argus Database or Aris-G for ICSR case processing.
4. Is this a remote job?
No, the job location is Gurugram or Pune, India.
5. What type of cases will I handle?
You will process Individual Case Safety Reports (ICSRs) for both clinical trial and post-marketing safety activities.
Conclusion
The Safety & PV Specialist I role at Syneos Health is an exceptional opportunity for qualified pharmacovigilance professionals who want to grow their careers in a globally respected organization. With its emphasis on innovation, regulatory compliance, and professional development, Syneos Health provides the ideal platform for advancing your PV expertise. Syneos Health Hiring for Safety / PV Specialist
If you have a strong background in ICSR case processing, Argus database, and global safety reporting, don’t miss this opportunity to join one of the world’s top biopharmaceutical solution providers. Syneos Health Hiring for Safety / PV Specialist
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Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
