Job Title
Safety & PV Specialist I
Company Overview
Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. With over 29,000 employees across 110 countries, we bring together clinical, medical affairs, and commercial insights to deliver outcomes that address modern market realities.
Our Clinical Development model keeps patients and customers at the center of everything we do. We continuously simplify and streamline processes to make Syneos Health not only easier to work with but also easier to work for.
Work Here Matters Everywhere
Why Join Us
Career development and progression opportunities
Supportive and engaged line management
Technical and therapeutic training programs
Peer recognition and total rewards program
Commitment to our Total Self culture, where authenticity and inclusivity thrive
A workplace that values diversity of thought, background, and perspectives
Key Responsibilities
Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs.
Assist in processing ICSRs in line with SOPs and project-specific safety plans.
Triage ICSRs; evaluate data for completeness, accuracy, and regulatory reportability.
Enter data into the safety database and ensure accurate MedDRA coding.
Compile complete narrative summaries.
Identify missing information, raise queries, and follow up until resolution.
Support generation of expedited regulatory reports in compliance with global requirements.
Maintain safety tracking and perform literature screening/review for safety purposes.
Conduct drug coding, maintain drug dictionaries, and manage MedDRA coding.
Validate and submit xEVMPD product records, including indication coding.
Manage duplicate ICSRs and un-recoded product/substance terms.
Support SPOR/IDMP activities.
Perform quality review of ICSRs.
Ensure relevant documentation is submitted to Trial Master File (TMF) and Pharmacovigilance System Master File.
Maintain compliance with SOPs, WIs, GCP, ICH, GVP, and regulatory requirements.
Build collaborative working relationships with internal and external project teams.
Participate in audits as required.
Apply Syneos Health’s regulatory intelligence to safety reporting activities.
Qualifications
Education and/or equivalent experience in life sciences, pharmacovigilance, or related field.
Familiarity with pharmacovigilance processes, safety databases, MedDRA coding, and regulatory guidelines preferred.
Strong attention to detail and ability to ensure compliance with global drug/device regulations.
Effective communication and collaboration skills.
Additional Information
Tasks and responsibilities listed are not exhaustive; additional duties may be assigned at the Company’s discretion.
Equivalent experience, skills, and/or education will be considered.
No part of this description constitutes an employment contract.
Syneos Health is committed to equal opportunity employment, compliance with global labor laws, and providing reasonable accommodations under the Americans with Disabilities Act.
About Syneos Health
Partnered on 94% of FDA Novel Drug Approvals in the past 5 years
Supported 95% of EMA Authorized Products
Conducted 200+ studies across 73,000 sites with over 675,000 trial patients
Learn more at: www.syneoshealth.com
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