Pharmacovigilance Scientist (Safety Aggregate Report Specialist)

1w1 week ago

IQVIA

Zagreb, HR · Full-time · €25,000 – €45,000

About this role

Our ever-growing Lifecycle Safety Medical team is expanding and hiring Pharmacovigilance Scientists (Safety Aggregate Report Specialists). Serve as principal owner of the SARA deliverable with responsibility for completion in compliance with all applicable service level agreements. This role focuses on safety aggregate reporting across multiple regions.

Act as primary author and/or reviewer/QCer of SARA deliverables involving aggregate reports, signal management, or literature review projects. Lead, author, and finalize small to medium aggregate reports including PBRERs/PSURs, DSURs, PADERs, ACOs, device reports, and line listings. Author responses to regulatory agency or PRAC inquiries as required.

Interface with clients and functional groups within Lifecycle Safety and other units like Regulatory Reporting, Medical Writing, and Safety Operations. Serve as the interface between the global project lead and the working team. Participate in internal and external audits and inspections as required.

Provide mentorship and training to less experienced resources. Contribute to departmental goals such as utilization realization and productivity metrics. Support technology and innovation activities while adhering to IQVIA SOPs and customer SOPs.

Requirements

Bachelor's Degree in a Scientific or Healthcare discipline, or equivalent combination of education, training and experience
1-2 years of prior relevant experience in areas of drug safety, aggregate reporting, signal management, or literature surveillance
Good understanding of Standard Operating Procedures
Ability to author aggregate reports like PBRERs/PSURs, DSURs, and PADERs
Experience in signal detection, validation, and evaluation
Knowledge of literature safety surveillance and ICSR identification
Familiarity with regulatory inquiries and PRAC responses

Responsibilities

Act as primary author and/or reviewer/QCer of SARA deliverables involving aggregate reports, signal management or literature review projects
Lead, author and finalize small to medium aggregate reports, including PBRERs/PSURs, DSURs, PADERs, ACOs, device reports, and line listings
Author responses to regulatory agency/PRAC inquiries
Act as literature lead, back-up lead, or reviewer/QCer for ongoing literature safety surveillance, identifying ICSRs and evaluating events of special interest
Act as Signal Management Specialist, author signal management deliverables, conduct signal detection, validation, and evaluation
Interface with clients and other functional groups within Lifecycle Safety and business units
Provide mentorship and training to less experienced resources
Participate in internal and external audits and inspections