Syneos Health, a global biopharmaceutical solutions leader, invites talented professionals to join its dynamic team. With a commitment to innovation and a Total Self culture, Syneos Health provides an environment where individuals can thrive. Explore two exciting roles that could be the next step in your career journey:
1. Senior Safety & Pharmacovigilance Submissions Specialist
Location: Gurugram, India
Job ID: 24007066-IND501
About the Role:
As a Senior Safety & Pharmacovigilance Submissions Specialist, you will collaborate with sponsors and project teams to ensure accurate, timely safety submissions across clinical trials. This role demands a strong understanding of regulatory requirements, medical terminology, and safety database systems.
Key Responsibilities:
- Design, prepare, and assemble expedited and periodic safety reports.
- Develop Safety Reporting Plans for projects.
- Ensure compliance with global safety regulations, ICH guidelines, and GVP.
- Provide regulatory advice on safety submissions to project teams and sponsors.
- Maintain meticulous documentation within Trial Master Files (TMF) and the Pharmacovigilance System Master File.
Qualifications:
- Bachelor’s degree in Life Sciences, Nursing, or Pharmacy.
- Minimum 5 years of experience in Safety & Pharmacovigilance, with expertise in safety submissions.
- Proficiency in Microsoft Office, safety databases, and medical terminology.
- Strong organizational and communication skills.
2. Senior Clinical Data Associate
Location: Remote (India)
Job ID: 25001154
About the Role:
The Senior Clinical Data Associate plays a pivotal role in ensuring the accuracy and integrity of clinical data across multiple studies. This role offers the chance to work on innovative projects while leveraging your expertise in data management systems.
Key Responsibilities:
- Perform data validation, User Acceptance Testing (UAT), and discrepancy management.
- Ensure consistency of external data such as lab reports and electronic diaries with clinical databases.
- Collaborate with cross-functional teams, including Biostatistics and Clinical Programming.
- Maintain proficiency in Clinical Data Management Systems (CDMS) and contribute to process improvements.
- Support audits and participate in study-specific meetings.
Qualifications:
- Bachelor’s degree in Life Sciences or equivalent.
- Experience in clinical data management, preferably within Phases II-IV clinical trials.
- Strong knowledge of CDMS, GCP guidelines, and SAS mapping.
- Excellent communication and organizational skills with the ability to multitask.
