Are you passionate about advancing patient safety in the biopharmaceutical industry? Syneos Health, a global leader in clinical research and pharmacovigilance, is hiring a Safety & PV Specialist I in Gurugram, India. This role offers an exciting opportunity to contribute to cutting-edge drug safety processes, ensuring compliance with global regulations while working with a diverse, innovative team. If you’re seeking a rewarding career in pharmacovigilance, this position at Syneos Health is your chance to make an impact.
Job Responsibilities
As a Safety & PV Specialist I, you will play a critical role in ensuring the safety of pharmaceutical products. Key responsibilities include:
- Data Entry and Tracking: Enter and manage Individual Case Safety Reports (ICSRs) in PVG quality and tracking systems per Standard Operating Procedures (SOPs).
- ICSR Processing: Triage, evaluate, and process ICSRs for completeness, accuracy, and regulatory reportability.
- Database Management: Input data into safety databases, code events, medical history, concomitant medications, and tests.
- Narrative Compilation: Create comprehensive narrative summaries for safety reports.
- Query Resolution: Identify missing information, follow up on queries, and ensure resolution.
- Regulatory Reporting: Assist in generating timely and accurate expedited safety reports per regulatory requirements.
- Literature Screening: Conduct literature reviews for safety, drug coding, and MedDRA coding as needed.
- xEVMPD Compliance: Validate and submit xEVMPD product records, including coding indication terms using MedDRA.
- Quality Control: Perform quality reviews of ICSRs and manage duplicate reports.
- SPOR/IDMP Activities: Support initiatives related to SPOR and IDMP compliance.
- Documentation: Ensure all relevant documents are submitted to the Trial Master File (TMF) or Pharmacovigilance System Master File as required.
- Compliance: Adhere to SOPs, Work Instructions, GCP, ICH guidelines, GVP, and global drug regulations.
- Collaboration: Foster professional relationships with internal and external project team members.
- Audits: Participate in audits as required, applying Syneos Health’s regulatory intelligence to safety reporting.
Qualifications
To excel in this role, candidates should meet the following qualifications:
- Education: Bachelor’s degree in life sciences, pharmacy, or a related field.
- Experience: Prior experience in pharmacovigilance, clinical research, or drug safety is preferred but not mandatory. Equivalent skills or transferable experience will be considered.
- Skills:
- Knowledge of pharmacovigilance processes, including ICSR processing and MedDRA coding.
- Familiarity with global drug safety regulations, GCP, ICH guidelines, and GVP.
- Strong attention to detail and analytical skills for data evaluation.
- Proficiency in safety databases and PVG systems.
- Excellent communication and teamwork skills.
- Certifications: Certification in pharmacovigilance or clinical research is a plus.
Syneos Health values diversity and encourages candidates with transferable skills to apply, even if their experience doesn’t perfectly align.
Benefits of Working at Syneos Health
Joining Syneos Health means becoming part of a global organization committed to employee growth and well-being. Benefits include:
- Career Development: Access to technical and therapeutic training, career progression opportunities, and peer recognition programs.
- Total Self Culture: A supportive, inclusive workplace where you can authentically be yourself.
- Global Impact: Contribute to 94% of FDA-approved drugs and 95% of EMA-authorized products over the past five years.
- Total Rewards: Competitive salary, comprehensive benefits, and a focus on work-life balance.
- Team Collaboration: Work with 29,000 professionals across 110 countries in a dynamic, innovative environment.
How to Apply
