Similar Jobs
See allQuality Analyst
Inizio Engage
Philippines
Pharmacovigilance
Quality Assurance
Microsoft Office
Associate Director - Compliance
Mineralys Therapeutics
US
Compliance
Policy Development
Risk Management
Manager of Patient Engagement
Shields Health Solutions
US
Leadership
Operations Management
Pharmacy
Growth Operations Program Manager
Vida
US
Program Management
Operations
Healthcare
Medical Information Specialist II
Inizio
Philippines
Microsoft Office
Communication
Pharmacovigilance
Vendor Oversight & Governance:
- Act as primary business owner and day-to-day liaison for outsourced vendor, managing operational relationship across full service scope.
- Lead regular governance meetings, monitor KPIs and SLAs, and coordinate change orders and budget tracking.
Medical Information Operations:
- Oversee end-to-end medical inquiry intake, triage, and fulfillment for HCPs and consumers via phone and email.
- Manage Scientific Response Letter process and partner with Scientific/Medical Communications on document maintenance.
Pharmacovigilance & Safety Intake:
- Ensure accurate adverse event documentation and timely transfer to Pharmacovigilance/Safety function.
- Oversee product quality complaint intake and maintain compliant separation between intake and case processing.
Systems Integration & Compliance:
- Partner with IT for seamless integration with Med Affairs technology stack (e.g., Veeva CRM, MedComms).
- Ensure all activities are compliant with GVP, GCP, and GMP, and support vendor audits and regulatory inspections.
Mineralys Therapeutics
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. The company is headquartered in Radnor, Pennsylvania, and operates as a fully remote organization with a collaborative culture.