You oversee case processing guidance and ensure regulatory compliance in clinical trials while managing safety reporting and ensuring data completeness for adverse event analyses.
Anforderungen
- •Bachelor's degree in health care profession
- •Long-standing experience in Pharmacovigilance
- •Ability to solve problems effectively
- •Strong communication and interpersonal skills
- •Proficiency in interpreting medical information
- •Fluent English skills, both written and spoken
Deine Aufgaben
- •Guide vendors, non-HCPs, and physicians on adverse event processes.
- •Complete individual case safety reports in Medical Review workflow.
- •Review Phase II and III Clinical Trial Protocols for PV compliance.
- •Identify and request additional medical data for adverse event cases.
- •Represent GCM in project teams and working groups.
Original Beschreibung
# Senior Triage and Review Specialist
**The Position**
Are you ready to make a difference in drug safety? As a Senior Triage & Review Specialist, you will be a key expert in adverse event data processing, ensuring accurate and timely handling of safety information from various sources. Your work will directly shape the safety profile of our investigational and marketed drugs, supporting critical regulatory and post-marketing processes.
In this role, you’ll provide guidance to vendors, local PV colleagues, and peers, while collaborating with GPV risk management physicians. Additionally, you’ll have the opportunity to contribute to global safety platform projects or coordinate phase II and III clinical trials.
If you’re passionate about patient safety and thrive in a dynamic, impactful environment, we’d love to hear from you!
**Tasks & responsibilities**
* You will guide case processing vendors, non-HCPs, peers, and physicians on adverse event intake, processing, and standard medical inquiries.
* Additionally, you will complete individual case safety reports in the Medical Review workflow activity within the global safety platform, adhering to strict timelines.
* You will review the Clinical Trial Protocol of Phase II and III trials, ensuring PV regulatory aspects are implemented.
* If necessary, you will apply clinical judgment to identify missing medical data in adverse event cases and request additional information, to ensure that adverse event data are complete for risk analysis.
* You will act as a GCM representative in project teams and working groups.
**Requirements**
* Bachelor's degree in a health care/life science-related profession or medical information science/data science
* Long-standing experience within the pharmaceutical industry, specifically in Pharmacovigilance
* Ability to make independent decisions and solve problems effectively combined with the capacity to prioritize workload and perform under stress in situations where working speed and sustained attention are critical
* Strong communication and interpersonal skills to effectively resolve issues and collaborate with inter/intra departments
* Proficiency in collecting, interpreting, and reconciling medical information in English
* Fluent English skills, both written and spoken