Associate Director, Global Aggregate Reporting & Risk Management Plans
Madrigal Pharmaceuticals
6 months ago
Remote friendly (Conshohocken, PA)
United States
Operations
Associate Director, Global Aggregate Reporting & Risk Management Plans
Key Responsibilities
- Serve as primary author for assigned aggregate safety reports (e.g., DSURs, PADERs, PBRERs) and Risk Management Plans (RMPs) by coordinating drafting through finalization for submission.
- Contribute to maintenance and tracking/monitoring of Core RMP and regional RMPs as new safety data emerge.
- Support global marketing authorization submissions and pharmacovigilance responses to regulatory information requests (under direction of the Senior Director).
- Ensure adherence to SOPs, global regulatory requirements, and inspection readiness for aggregate reporting and RMP activities.
- Identify process improvement opportunities and optimize aggregate reporting and RMP processes.
- Other duties as assigned.
Required & Desired Qualifications
- Demonstrated experience planning, coordinating, and executing aggregate safety reports (DSURs, PADERs, PBRERs).
- Working knowledge of development, maintenance, and lifecycle management of Core and Regional RMPs.
- Solid understanding of global pharmacovigilance regulations and reporting requirements.
- Strong scientific/clinical acumen to synthesize safety data and communicate risk.
- Highly organized, detail-oriented, able to manage multiple deliverables in a fast-paced environment.
- Effective collaboration across matrixed teams and with external vendors.
- Comfort with increasing autonomy while escalating issues appropriately.
- Ability to apply SOPs consistently and support compliance with evolving regulatory expectations.
- Proficient with electronic safety systems and document management tools (e.g., Argus).
- Minimum Bachelor’s degree in a relevant scientific discipline required; Advanced degree preferred (e.g., PharmD, PhD, NP/PA).
- Minimum 10 years clinical safety or pharmacovigilance experience in pharmaceutical/biotech; demonstrated aggregate safety reporting and risk management experience.
- Prior experience with safety databases/systems (e.g., Argus).
- Plus: experience supporting global regulatory submissions and collaborating with external vendors.
- Travel: up to 10%.
Benefits
- Full-time employees may be eligible for bonus, equity, and comprehensive benefits including flexible paid time off (4 weeks vacation, 1-week sick time, 2 float days), medical, dental, vision, and life/disability insurance, plus 401(k) and voluntary benefits; mental health benefits via Employee Assistance Program.
Application Instructions
- Submit applications on an ongoing basis via the Madrigal Careers site.
Key Responsibilities
- Serve as primary author for assigned aggregate safety reports (e.g., DSURs, PADERs, PBRERs) and Risk Management Plans (RMPs) by coordinating drafting through finalization for submission.
- Contribute to maintenance and tracking/monitoring of Core RMP and regional RMPs as new safety data emerge.
- Support global marketing authorization submissions and pharmacovigilance responses to regulatory information requests (under direction of the Senior Director).
- Ensure adherence to SOPs, global regulatory requirements, and inspection readiness for aggregate reporting and RMP activities.
- Identify process improvement opportunities and optimize aggregate reporting and RMP processes.
- Other duties as assigned.
Required & Desired Qualifications
- Demonstrated experience planning, coordinating, and executing aggregate safety reports (DSURs, PADERs, PBRERs).
- Working knowledge of development, maintenance, and lifecycle management of Core and Regional RMPs.
- Solid understanding of global pharmacovigilance regulations and reporting requirements.
- Strong scientific/clinical acumen to synthesize safety data and communicate risk.
- Highly organized, detail-oriented, able to manage multiple deliverables in a fast-paced environment.
- Effective collaboration across matrixed teams and with external vendors.
- Comfort with increasing autonomy while escalating issues appropriately.
- Ability to apply SOPs consistently and support compliance with evolving regulatory expectations.
- Proficient with electronic safety systems and document management tools (e.g., Argus).
- Minimum Bachelor’s degree in a relevant scientific discipline required; Advanced degree preferred (e.g., PharmD, PhD, NP/PA).
- Minimum 10 years clinical safety or pharmacovigilance experience in pharmaceutical/biotech; demonstrated aggregate safety reporting and risk management experience.
- Prior experience with safety databases/systems (e.g., Argus).
- Plus: experience supporting global regulatory submissions and collaborating with external vendors.
- Travel: up to 10%.
Benefits
- Full-time employees may be eligible for bonus, equity, and comprehensive benefits including flexible paid time off (4 weeks vacation, 1-week sick time, 2 float days), medical, dental, vision, and life/disability insurance, plus 401(k) and voluntary benefits; mental health benefits via Employee Assistance Program.
Application Instructions
- Submit applications on an ongoing basis via the Madrigal Careers site.