Job Title: Sr. Associate, Aggregate Report Compliance
Job ID: 24-02289
Location: Remote
Duration: 12 months on W2 Contract.
Notes from HM:
- Role can be 100% REMOTE.
- May travel for a possible mandatory meeting onsite for 1-2 days, not very often at all.
- 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.
Description:
Sr. Associate, Aggregate Report Compliance
In conjunction with the Manager of Aggregate Report Compliance and Vendor Oversight, the Sr. Associate, Aggregate Report Compliance will support the oversight of the aggregate report tracking process and compliance monitoring of aggregate report submissions to Health Authorities.
In support of aggregate report compliance, the individual will be responsible for supervising compliance and ensuring appropriate documentation is completed when there are late submissions to Health Authorities.
The Sr. Associate, Aggregate Report Compliance will generate compliance metrics and reports in support of MSQ Compliance and Risk Management key partners, including:
- Office of the Chief Medical Officer (OCMO) Senior Leadership Team
- Office of the QPPV
- Global Regulatory Affairs
- International Pharmacovigilance Leadership
- Other partners across business
Required Knowledge, Skills and Abilities:
- Knowledge of GxP requirements and experience with safety processing, clinical safety study reporting, PV and medical information preferred
- Ability to function 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.
Required Minimum Education:
- 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.