Are you passionate about ensuring drug safety and pharmacovigilance in the biopharmaceutical industry? Syneos Health, a leading fully integrated biopharmaceutical solutions organization, is hiring a Safety & Pharmacovigilance Coordinator in Hyderabad, India. This is an exciting opportunity to join a global team dedicated to accelerating customer success and improving patient outcomes.
Job Description
As a Safety & Pharmacovigilance Coordinator, you will play a critical role in ensuring the safety and compliance of pharmaceutical products. Your responsibilities will include:
- Monitoring and Routing Information: Manage incoming safety data and route it to the appropriate projects as required.
- Documentation and Tracking: Record Individual Case Safety Reports (ICSRs) and track them in accordance with Sponsor/customer specifications.
- Data Entry: Enter safety data into the safety database, adhering to Sponsor-specific guidelines and company standards.
- File Management: Create, track, retain, and maintain both paper and electronic files.
- Translation and Query Management: Oversee the translation of source documents and assist with query follow-up processes.
- Regulatory Compliance: Assist in generating timely and accurate expedited reports in compliance with regulatory requirements.
- Coding and Validation: Assist with MedDRA coding, drug coding, and validation of xEVMPD product records.
- Audit Participation: Participate in audits as required and ensure all documents are submitted to the Trial Master File (TMF) or Pharmacovigilance System Master File (PSMF).
- Team Collaboration: Foster professional relationships with internal and external project team members.
Qualifications
To be successful in this role, you should have:
- A Bachelor’s Degree in life sciences, nursing, pharmacy, or equivalent experience.
- Familiarity with safety database systems and medical terminology.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and shared workspace tools.
- Strong organizational, communication, and interpersonal skills.
- Attention to detail and the ability to prioritize multiple tasks effectively.
- Knowledge of ICH GCP, GVP modules, and global drug/biologic/device regulations is preferred.
Why Syneos Health?
Syneos Health is a global leader in biopharmaceutical solutions, working with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products. Here’s why you should join us:
- Career Development: We are passionate about developing our people through training, career progression, and supportive management.
- Total Self Culture: We foster an inclusive environment where you can authentically be yourself.
- Global Impact: With over 29,000 employees across 110 countries, your work here matters everywhere.
- Innovation: We bring together diverse thoughts, backgrounds, and perspectives to create a place where everyone feels they belong.
