Job Summary:
Perform data entry of cases received via email, fax, or postal service. Monitor and perform activities required to fulfill the periodic regulatory reporting requirements for clients. Maintain distinctive quality and commitment as the operating philosophy in carrying out all processes. Continually seek out ways to enhance customer service experience both internally and externally.
Essential Functions:
- Drug Safety inbox of client communication and assist with triaging questions
- Case Entry
- Enter new cases into the safety database and all new case information for existing cases received from clients via email or postal service
- Attach new follow-up files to Case Explorer and ARGUS
- Enter reportable literature cases
- Regulatory Reporting
- Complete MedWatch activities including final review, monitoring MedWatch completion and submitting to the client or FDA as appropriate
- Update Safety Database case notes when applicable
- Generate third-party manufacturing reports
- Product Complaint
- Coordinate retrieval process for select client companies
- Monitor and coordinator Master Reports for annual literature reports and submit to client
- Monitor reporting requirements for SDEA when applicable
- Other duties as assigned.
Necessary Skills and Abilities:
- Proficient computer knowledge and computer keyboarding skills
- Computer data entry experience
- Excellent attention to detail
- Strong verbal, written and interpersonal communication skills
- Strong organization and prioritization skills, able to multitask
- Flexibility to adapt and meet fluctuating business priorities
- Ability to work independently and within a team
Education Requirements:
- Preferred: Post-secondary non degree award (Nursing Assistant, Paramedic, EMT, Pharmacy Technician, Veterinary Technician)
Experience Requirements:
- Preferred: 2 years of healthcare related work experience
- Preferred: Familiar with Microsoft Office Suite (Outlook, Word, Excel)
- Preferred: Experience working with safety databases
*CO candidates may not be considered