Pharmacovigilance Operations Manager I
About the role
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- Prioritizing and complete multiple projects within established time frames.
- Managing client projects, including managing client relationships and project budgets.
- Entering source information for ICSRs into safety databases and/or tracking systems ensuring accurate data-entry.
- Preliminary triaging of ICSRs to determine classification, priorities and time frames for subsequent activities.
- Performing preliminary coding of ICSRs using MedDRA, WHODrug and database-specific dictionaries.
- Completion project-specific report forms with available information for ICSRs.
- Preparing draft narratives for ICSRs.
- Medical review of ICSRs, only if medically qualified (physician, pharmacist, nurse).
- Performing quality control review of ICSRs to ensure accuracy and completeness of data-entry.
- Contacting reporters of ICSRs to collect additionall information, supporting documents and answers to queries within pre-defined parameters.
- Determine if ICSRs require submission to clients, client contract partners, and/or regulatory agencies.
- Submitting ICSRs to regulatory agencies in accordance with pre-determined documented distribution rules. This may include submissions by fax, email, courier or E2B.
- Registering clients for and maintaining registrations of clients for electronic ICSR submissions to regulatory agencies.
- Distributing ICSRs to clients or client contract partners in accordance with pre-determined documented distribution rules.
- Participating as an active member of multidisciplinary teams to successfully achieve project and corporate goals. Identifying project issues and developing proposals for alternative strategies for discussion with superiors.
- Mentoring less-experienced team members.
- Other duties as determined.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. Learn more about Our Culture at ICON
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