Job Description: Safety & PV Specialist I
Company: Syneos Health®
Location: [Insert Location]
Employment Type: [Full-time/Contract]
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success. With over 29,000 employees across 110 countries, we bring together clinical, medical affairs, and commercial expertise to deliver outcomes that change lives.
We are committed to fostering a culture where every employee can authentically be themselves, grow professionally, and contribute to meaningful work that matters everywhere.
Why Join Us
Career development and progression opportunities.
Supportive leadership and engaged line management.
Technical and therapeutic area training.
Peer recognition and total rewards program.
Inclusive Total Self Culture that values diversity of thoughts, backgrounds, and perspectives.
Key Responsibilities
Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs.
Assist in ICSR processing as per SOPs and project/program-specific safety plans.
Triage ICSRs, evaluate data for completeness, accuracy, and regulatory reportability.
Enter and maintain data in safety databases.
Perform MedDRA coding of events, medical history, concomitant medications, and tests.
Draft narrative summaries of case reports.
Identify, query, and follow up on incomplete information until resolution.
Support expedited reporting in compliance with regulatory requirements.
Maintain safety tracking logs for assigned activities.
Conduct literature screening and review for safety surveillance.
Manage xEVMPD product records including MedDRA indication coding.
Handle manual recoding of un-coded product/substance terms from ICSRs.
Identify and manage duplicate ICSRs.
Participate in SPOR/IDMP-related activities.
Perform quality reviews of ICSRs.
Ensure submission of all relevant documents to:
Trial Master File (TMF) for clinical trials.
Pharmacovigilance System Master File (PSMF) for post-marketing programs.
Stay compliant with SOPs, WIs, GCP, ICH, GVP, and global drug/device regulations.
Build professional working relationships with internal and external stakeholders.
Support audits as required.
Apply safety reporting regulatory intelligence to day-to-day activities.
Qualifications
[Insert educational qualifications, e.g., Life Sciences degree preferred].
Familiarity with pharmacovigilance processes, ICSR handling, and MedDRA coding.
Knowledge of global regulatory guidelines (ICH, GCP, GVP).
Strong attention to detail and ability to manage multiple tasks.
Good communication and collaboration skills.
About Syneos Health in Numbers
Partnered in 94% of all Novel FDA Approved Drugs over the past 5 years.
Contributed to 95% of EMA Authorized Products.
Supported 200+ studies across 73,000 sites and 675,000+ trial patients.
Additional Information
Tasks and responsibilities listed are not exhaustive. Additional duties may be assigned as needed.
Equivalent experience, skills, or education may be considered.
This description does not constitute an employment contract.
Syneos Health is committed to diversity, inclusion, and compliance with all applicable employment laws, including reasonable accommodations under the Americans with Disabilities Act (ADA).
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