- Role can be 100% REMOTE.
- May travel for a possible mandatory meeting onsite for 1-2 days, not very often.
- Bachelor's degree required.
- Pharmacovigilance experience needed.
- Must be flexible / adaptive.
- Must be able to problem solve and know when to ask for help.
- Working within the Global Environment / Global Teams
- Regulatory Affairs experience
- MAIN ASPECT OF ROLE: Support Aggregate Tracking process
- Must be able to spot if data is incorrect on report.
- Office of the Chief Medical Officer (OCMO) Senior Leadership Team
- Office of the QPPV
- Global Regulatory Affairs
- International Pharmacovigilance Leadership
- Other partners across business
- Knowledge of GxP requirements and experience with safety processing, clinical safety study reporting, PV and medical information preferred
- Ability to operate in a global matrix environment
- Excellent communication and writing skills
- Understanding of and experience with multi-cultural working is preferred
- Project Management experience with organizing actions and managing team activities is preferred
- Proficiency in Microsoft Excel and SharePoint is required
- Requires problem-solving skills to interpret and analyze data and information
- Experience in high volume work environment preferred.
- Minimum of Bachelor's Degree in relevant discipline (Business, Science, Medical, Operations, etc.) with 4 years of pharmaceutical industry experience or advanced academic degree with 2 years of pharmaceutical industry experience.
- Required Years of Related Experience: Minimum of 2 years of experience in pharmacovigilance case processing, aggregate reporting, and/or PV compliance monitoring.
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Sr. Associate, Aggregate Report Compliance - Atlanta, United States - Sunrise System Inc
Description
Job Title: Sr. Associate, Aggregate Report Compliance
Location: Remote
Duration: 12 months on W2 Contract.
Description:
Sr. Associate, Aggregate Report Compliance
In collaboration with the Manager of Aggregate Report Compliance and Vendor Oversight, the Sr. Associate, Aggregate Report Compliance will assist in monitoring the aggregate report tracking process and ensuring compliance in aggregate report submissions to Health Authorities.
For compliance with aggregate reporting, the individual will oversee compliance and ensure proper documentation in cases of late submissions to Health Authorities.
The Sr. Associate, Aggregate Report Compliance will produce compliance metrics and reports supporting MSQ Compliance and Risk Management key allies:
