Job Title: Senior Post Marketing Study Lead
Location: Remote
Job Summary: We are seeking a driven professional to ensure compliance and quality in post-marketing pharmacovigilance operations. Our team is committed to supporting effective safety data management, workflow coordination, and regulatory reporting for impactful pharmaceutical studies.
Responsibilities:
- Oversee and manage high-quality adverse event case processing, including data entry, coding, review, and quality assurance for post-marketing cases.
- Manage and coordinate pharmacovigilance vendors, providing training, workflow guidance, and ensuring compliance with global regulations.
- Support operational process improvement, study setup, protocol review, and configuration activities in post-marketing safety management.
- Collaborate cross-functionally on inspection readiness, develop training materials, and contribute to regulatory reporting and aggregate data analysis.
Required:
- 10+ years of pharmaceutical drug safety or pharmacovigilance experience, with demonstrated case processing and safety data management expertise.
- Comprehensive knowledge of FDA and international regulations related to adverse event and ICSR requirements, with proven ability to interpret and apply these regulations.
- Bachelor’s degree in a health-related or biological science-related field.
- Proficiency with safety database applications, MedDRA coding, and standard office software (Word, Excel, Outlook).
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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