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- Monitoring and managing project specific email accounts, incoming faxes and telephone calls. Preliminary triaging of ICSRs to determine classification, priorities and time frames for subsequent activities.
- Enter source information for ICSRs to safety databases, tracking systems and/or project specific report forms ensuring accurate data entry
- Performing preliminary coding of ICSRs using MedDRA, WHODrug and database-specific dictionaries.
- Preparing draft narratives for ICSRs.
- Submitting ICSRs to regulatory agencies, clients or client partners in accordance with predetermined documented distribution rules.
- Responding to logistics enquiries from investigators and site staff participating in Mapi studies.
- Preparing ICSR files for the purposes of third party review including adjudication, review by Drug Safety Monitoring Boards, etc.
- Build and maintain positive and productive liaison with internal and external contacts.
- Effectively prioritize and complete multiple projects within established time frames.
- Identify client issues and develop alternative strategies for consultation with other managers.
- Participate in and support project teams and advise other departments on regulatory issues and strategies.
- Participate and assist in preparations for regulatory inspection/internal audits.
- Other duties as assigned.
Qualifications:
- 4 year degree or equivalent experience
- Sound written and verbal communication skills
- Direct experience and working knowledge of adverse event reporting
- Ability to build positive, productive relationships with colleagues and clients
- Strong computer skills and training in current software applications (MS Office, MS Excel)
- Demonstrates organizational, planning and problem solving skills
- Travel less than 10% annually
Knowledge/Skills/Abilities:
- Displays full knowledge of protocol, regulatory requirements, and company SOPs.
- Identifies, documents, and discusses protocol violations, regulatory non-compliance, and issues involving subject safety.
- Distinguishes between good practice and regulatory requirements.
- Applies knowledge into practice on-site.
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