Adverse Events Case Manager
4 semanas atrás
Job Summary: We are seeking a highly skilled Drug Safety Specialist to join our team at Organon. The successful candidate will be responsible for managing adverse events case management, including case intake and follow-up activities in accordance with Global Pharmacovigilance procedures and country regulations.
Key Responsibilities:
- Intake of cases received from designated points of contact, vendors, and business partners for Individual Case Safety Reports (ICSRs), including tracking and translation to English and forwarding of information to the Data Management Center.
- Performing ICSR acknowledgments and reconciliation activities.
- Executing local PV processes and activities in alignment with PV systems and their associated Quality Management System, following department SOPs, company policies and procedures, and country legislation.
- Reconciliation activities for PV cases received from local operating units and contractual partners, and processing reports in accordance with local procedures/PV legislations.
- Providing support for Patient Support Programs (PSP) and/or Market Research vendor-related activities, as applicable.
- Filing, storing, and archiving safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.
Requirements:
- Candidates with excellent communication and interpersonal skills.
- Strong analytical and problem-solving skills.
- Ability to work in a fast-paced environment and manage multiple tasks simultaneously.
- Proficiency in Microsoft Office and ability to learn new software systems.
- Fluency in Spanish and Portuguese, with English as the primary language of communication.
What We Offer:
- A competitive salary and benefits package.
- Opportunities for professional growth and development.
- A dynamic and supportive work environment.
About Organon:
We are a global healthcare company dedicated to improving the lives of patients around the world. Our mission is to drive innovation and deliver high-quality products and services that meet the evolving needs of our customers.
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