Please note that this is a 1 year contract position.
HIGHLIGHTED SKILLS:
- Role can be 100% REMOTE
- May travel for a possible mandatory meeting onsite (Raritan, NJ) for 1-2 days, not very often at all
- Bachelors 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
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.
In conjunction with the Manager of Aggregate Report Compliance and Vendor Oversight, the 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 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
Compliance metrics and data produced feed into:
Quality Management Reviews
Medical Safety Council Operational Compliance Committees
Other compliance review venues and for other functional partners
The individual will drive the precision and consistency of compliance metrics and be responsible for ensuring that publication of all standard compliance metrics are completed in a timely, accurate and consistent fashion and will innovate by streamlining processes and driving efficiencies.
Keys for success in this role include the ability to develop partnerships with Global Regulatory Affairs, Local Operating Companies, and strategic vendor colleagues.
Support the aggregate report tracking process and systems
Monitor compliance of aggregate report submissions to Health Authorities and generation of compliance metrics
OTHER DUTIES
The individual, with oversight from the Manager of Aggregate Report Compliance and Vendor Oversight, will be accountable for prioritizing and ensuring that deliverables are completed on time and are accurate and consistent. The individual will follow documented processes and procedures for aggregate report compliance monitoring and metrics generation.
Applicants must provide their phone number. Reference job number A4070.
Regulatory/ Pharmacovigilance Associate (REMOTE)