Safety Aggregate Report Specialist
On-sitePasig City, Metro Manila, Philippines
Job Summary
Lead author and finalize aggregate reports including PBRERs, PSURs, DSURs, and RMPs while managing signal management activities for marketed and investigational products. Conduct ongoing literature safety surveillance, identify ICSRs, and perform signal validation to characterize risks. Serve as principal owner of SARA deliverables, ensuring compliance with service level agreements and regulatory agency inquiries. Interface with clients, functional groups, and project leads to cascade information and manage safety teams. Participate in internal and external audits, provide mentorship to resources, and report project metrics to management. Adhere to IQVIA and customer SOPs, maintain Good Documentation Practices, and contribute to departmental productivity goals.
Required Qualifications
- Bachelor's Degree In a Scientific or Healthcare discipline
- 2 - 3 years relevant work experience
- Equivalent combination of education, training and experience
- Excellent knowledge of Lifecycle Safety services and processes
- Willingness and aptitude to learn new skills across Lifecycle Safety service lines
- In depth knowledge and understanding of applicable global, regional, local regulatory requirements. i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs
- Proven ability to meet strict deadlines
- Manage competing priorities and ability to be flexible and receptive to changing demands
- Excellent organizational skills and time management skills
- Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint)
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