Location: Gurugram, India
Job ID: 25102900
Last Updated: Yesterday
Join Syneos Health – Where Every Role Shapes Global Healthcare
At Syneos Health®, we are more than a leading biopharmaceutical solutions organization—we are a global community united by a mission: to accelerate innovation and deliver life-changing therapies to patients worldwide. By bridging clinical development, medical affairs, and commercial expertise, we transform complex healthcare challenges into actionable solutions that impact millions.
With 29,000 employees across 110 countries, we pride ourselves on fostering an environment that champions creativity, scientific rigor, and operational excellence. At Syneos, your contributions are meaningful, your growth is prioritized, and your ideas can shape the future of healthcare.
WORK HERE MATTERS EVERYWHERE.
Why Syneos Health Is the Employer of Choice
We believe that cultivating talent, embracing diversity, and nurturing innovation are key to our success. When you join Syneos Health, you join a culture that empowers you to achieve your professional potential while making a real-world difference.
Career Growth & Learning Opportunities
- Tailored development programs, continuous learning, and mentorship opportunities
- Access to world-class training in pharmacovigilance, clinical research, and regulatory compliance
- Clear career progression pathways within a global, high-impact organization
Inclusive & Supportive Work Culture
- A “Total Self” environment that celebrates individuality and authenticity
- Diversity of thought, background, and perspective drives innovation and better decision-making
- Opportunities to collaborate with experts from across the globe, sharing ideas and best practices
Mission-Driven Work
- Your work directly supports the safety and efficacy of new and existing therapies
- Contribute to improving patient outcomes and advancing global healthcare standards
Position Overview: Safety & PV Trainee
This is an entry-level, high-impact role designed for fresh graduates from Delhi NCR who aspire to build a career in pharmacovigilance and drug safety. As a Safety & PV Trainee, you will gain hands-on exposure to global drug safety processes, adverse event reporting, case management, regulatory compliance, and quality assurance practices.
This position is contractual for one year, with potential for continuation based on performance and business needs.
Key Responsibilities
As part of our Safety & PV team, you will play a pivotal role in ensuring patient safety and regulatory compliance through meticulous data handling, case management, and collaborative problem-solving. Your responsibilities will include:
1. Case Intake, Triage, and Data Entry
- Receive, review, and enter Individual Case Safety Reports (ICSRs) into PVG quality and tracking systems
- Conduct thorough triage of cases to evaluate completeness, accuracy, and regulatory reportability
- Maintain detailed safety records and ensure timely database updates
2. Medical Coding and Narrative Preparation
- Accurately code adverse events, concomitant medications, medical histories, and laboratory tests using MedDRA
- Compile detailed and clinically relevant narrative summaries that support regulatory submissions
- Ensure clarity, accuracy, and adherence to SOPs in all documentation
3. Query Resolution & Data Clarification
- Identify missing or unclear information in case reports
- Collaborate with cross-functional teams to obtain accurate and complete data
- Track and resolve queries to ensure timely reporting and regulatory compliance
4. Regulatory Reporting & Compliance
- Assist in the preparation and submission of expedited safety reports per global regulatory requirements
- Maintain awareness of local and international regulations (GCP, ICH, GVP) and apply them consistently in daily tasks
- Participate in audits and inspections as required, contributing to quality assurance initiatives
5. Literature Review & Drug Safety Research
- Conduct literature screening to identify safety signals and emerging adverse events
- Maintain drug dictionaries, perform manual recoding, and manage product records in compliance with xEVMPD, SPOR, and IDMP guidelines
6. Quality Control & Documentation
- Ensure the accuracy and completeness of case reports through rigorous quality checks
- Identify and manage duplicate ICSRs to maintain data integrity
- Archive essential documents accurately in Trial Master File (TMF) or Pharmacovigilance System Master File (PSMF)
7. Collaboration & Teamwork
- Work closely with internal teams, sponsors, and external stakeholders to ensure seamless operations
- Apply regulatory intelligence and best practices in all safety reporting activities
- Contribute proactively to process improvements and continuous learning initiatives
Eligibility & Educational Requirements
- Fresh graduates from Delhi NCR passing out in 2025
- Qualifications accepted:
- M.Pharm
- Pharm.D
- M.Sc + B.Pharm
- BHMS
- BDS
- Ph.D. (Pharmacy)
Core Skills & Competencies
- Strong scientific foundation and genuine interest in healthcare and pharmacology
- Proficiency in Microsoft Office Suite and Outlook
- Exceptional organizational, documentation, and multitasking abilities
- Excellent written and verbal communication skills
- High attention to detail and accuracy
- Ability to collaborate effectively in a fast-paced, team-oriented environment
Preferred Skills
- Basic familiarity with pharmacovigilance concepts, safety databases, and regulatory reporting
- Understanding of medical terminology and drug safety processes
- Experience with collaboration and productivity tools such as Visio, Team Share, or equivalents
- Analytical mindset with problem-solving abilities
Syneos Health – Impact at a Glance
- Contributed to 94% of all novel FDA-approved drugs in the last 5 years
- Supported 95% of EMA-authorized products
- Managed 200+ global clinical studies, across 73,000+ sites, impacting 675,000+ trial patients
Discover more about our work at: www.syneoshealth.com
Additional Information
- Responsibilities outlined are indicative; additional tasks may be assigned based on business needs
- Qualifications may be substituted with equivalent experience at the company’s discretion
- This description does not constitute an employment contract
- Committed to compliance with global employment laws, including ADA requirements
How to Apply
If you are passionate about drug safety, pharmacovigilance, and healthcare innovation, click Apply Now on our website. Not ready to apply immediately? Join our Talent Network to stay updated on future opportunities.
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Diversity & Inclusion Statement
At Syneos Health, we are committed to creating a diverse, inclusive, and authentic workplace. We encourage all candidates to apply, even if your experience does not perfectly align with the job description. Transferable skills, enthusiasm, and the desire to learn are valued highly.
