ICON

Advanced degree in Life Sciences, Pharmacy, Medicine, or related field, with a minimum of 3-5 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization industry.

Your focus will be on coordinating pharmacovigilance and drug safety delivery, resolving issues, and developing team capability.

Assist Data Management Study Lead in maintenance of eCRF, Data Validation Specifications, and Study Specific Procedures. Manage clinical and third-party data reconciliation based on edit specifications and data review plans. ICON plc

Bachelors degree in pharmacy, life sciences, or a related field. Basic understanding of pharmacovigilance principles and regulatory guidelines is desirable but not required; relevant training will be provided. ICON plc

Strong working knowledge of Adobe Acrobat and Microsoft Word is essential. Advanced computer proficiency required, including expert knowledge of Microsoft Word templates, automation, styles and adobe QC tools.

Must have TMF, Trial Master File experience and strong knowledge of Clinical Studies documents. Ability to successfully liaise with study project teams, staff, clients and management, as necessary.

To effectively review visit reports as per Protocol and ICON and Sponsor SOPs and to ensure the quality of reports are of the highest standards , errors are minimized and that issues are escalated as appropriate

Plan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards.

Seeking a Pharmacovigilance Project Lead to join our diverse and dynamic team. As a Pharmacovigilance Project Lead at ICON, you will oversee the strategic management of safety monitoring and reporting for clinical trials and post-marketing activities.