Job Posting: Safety Specialist II – ICSR Case Processing
Summary:
Join Syneos Health, a global leader in biopharmaceutical solutions, as a Safety Specialist II – ICSR Case Processing. This role is perfect for experienced Pharmacovigilance professionals with a strong understanding of ICSR processing, MedDRA coding, and global regulatory guidelines. Based in Gurgaon, Hyderabad (Hybrid), or Pune (Hybrid), you’ll contribute to critical drug safety processes, ensuring the safety of patients worldwide. This is an opportunity to advance your career in a stable, growth-oriented environment with global exposure.
About Syneos Health:
At Syneos Health, we are dedicated to accelerating the delivery of therapies to patients worldwide. We support 94% of FDA-approved novel drugs in the past five years, a testament to our commitment to innovation and excellence. We foster a supportive “Total Self” culture that values authenticity and well-being, and we offer a strong learning ecosystem, comprehensive career development programs, and competitive total rewards.
Why Join Our Pharmacovigilance Team?
- Global Impact: Contribute to critical drug safety processes on a global scale.
- Career Growth: Benefit from a strong learning ecosystem and diverse career advancement opportunities.
- Supportive Culture: Thrive in a collaborative and innovation-driven environment that promotes authenticity and well-being.
- Cutting-Edge Work: Be part of a team supporting the development and safety of novel therapies.
- Comprehensive Training: Receive thorough onboarding and ongoing technical training to enhance your skills.
Job Responsibilities:
As a Safety Specialist II – ICSR Case Processing, your key responsibilities will include:
- ICSR Data Entry: Accurately enter Individual Case Safety Report (ICSR) details into Pharmacovigilance (PV) quality and tracking systems.
- ICSR Triage and Assessment: Perform ICSR triage, completeness checks, and regulatory reportability assessments.
- Safety Database Entry: Enter cases into safety databases, ensuring accurate MedDRA coding.
- Narrative Summary Preparation: Prepare high-quality narrative summaries of ICSRs.
- Information Gathering: Identify missing information and proactively follow up on safety queries to ensure complete case documentation.
- Regulatory Reporting: Support timely expedited and periodic reporting in compliance with global regulations.
- Duplicate Management: Manage duplicate ICSR identification and resolution.
- Literature Screening: Perform literature screening to identify potential safety signals.
- Drug Dictionary Maintenance: Contribute to the maintenance of drug dictionaries.
- xEVMPD and IDMP Activities: Validate and submit xEVMPD product records using MedDRA and conduct SPOR/IDMP-related activities.
- Quality Review: Perform quality review of processed cases to ensure accuracy and completeness.
- Documentation Management: Ensure proper documentation within the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF).
- Compliance: Maintain compliance with Standard Operating Procedures (SOPs), Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP), and International Council for Harmonisation (ICH) guidelines.
- Audit Participation: Participate in audits as required to ensure compliance with regulatory standards.
Qualifications & Skills Required:
To be successful in this role, you should possess the following qualifications and skills:
- Education: Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field.
- Knowledge: Strong knowledge of Medical Terminology, Safety Databases, and the ICSR lifecycle.
- Understanding: Thorough understanding of Phase II–IV clinical trials and post-marketing Pharmacovigilance requirements.
- Technical Skills: Proficiency in Microsoft Office tools and shared workspace systems.
- Communication: Excellent written and verbal communication skills.
- Attention to Detail: Strong attention to detail, accuracy, and ability to meet timelines.
- Teamwork: Ability to work both independently and collaboratively within a team environment.
Benefits of Working at Syneos Health:
- Global PV Process Exposure: Gain valuable experience in global Pharmacovigilance processes.
- Career Advancement Opportunities: Explore diverse career advancement opportunities within a growing organization.
- Comprehensive Training: Receive thorough onboarding and ongoing technical training.
- Supportive Leadership: Benefit from supportive leadership and employee recognition programs.
- Diverse and Inclusive Culture: Work in a diverse and inclusive environment that values every individual.
How to Apply:
If you are a motivated and experienced Pharmacovigilance professional looking for a challenging and rewarding opportunity, we encourage you to apply. Please click on the link below to submit your application.
We look forward to hearing from you!
