FSP Pharmacovigilance Coordinator
Posted 3 hours ago
You'll complete your application on Thermo Fisher Scientific's career site.
About the Role
As a Pharmacovigilance Coordinator, you will provide critical support and project management for a variety of domestic and international safety initiatives. This position is vital to the success of clinical research operations, ensuring all safety surveillance and study documentation adhere to strict regulatory and internal benchmarks. You will operate within a team-oriented setting to foster clear communication among project staff, clients, and regulatory agencies, supporting the objective of advancing public health and safety through scientific excellence.
Requirements
- You need a high school diploma or equivalent, plus relevant vocational training.
- You must have at least two years of relevant work experience or demonstrate an equivalent level of capability.
- You must be proficient in computer software, specifically the Microsoft Office suite.
- You should possess strong analytical problem-solving skills, excellent verbal and written communication abilities, and the capacity to function autonomously.
- You require knowledge of ICH Good Clinical Practices and FDA regulations to maintain compliance.
- You must maintain high attention to detail, act professionally under high-pressure situations, and be flexible regarding shifting schedules and varying project hours.
Responsibilities
- You will oversee the administrative and operational components of clinical safety projects.
- Your tasks include organizing the review of serious adverse events and protocol-related queries.
- You will handle the logistics for DSMB and EAC meetings and draft key paperwork like adjudication dossiers and confidentiality agreements.
- You will track project information, create client reports, and ensure audit preparedness through accurate record-keeping and system maintenance.
- You will handle incoming questions, coordinate project-specific training, and redact personal information to protect subject privacy.
- You will perform reconciliations across internal and external databases to verify the status of project deliverables.
Benefits & Perks
- This role is performed entirely from a remote location with a consistent Monday to Friday work schedule.
- You may be eligible for professional development training.
- Occasional travel to specific locations may be required.
Note: This listing is summarized and paraphrased by WorkNow from a publicly posted role. For the original wording and full details, please refer to the employer's official posting.
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