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Associate Director - Medical Information, Pharmacovigilance Contact Center Operations
MDWerks Inc.Associate Director/Director managing the Medical Information Contact Center operations at Mineralys. Responsible for vendor relations, safety compliance, and inquiry processing within the pharmaceutical domain.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing vendor relationships and overseeing Medical Information and Pharmacovigilance operations, ensuring compliance with regulatory frameworks and performance metrics. Proficient in training and knowledge transfer processes for vendor staff to maintain high standards of inquiry handling and adverse event reporting.
Highest-signal resume keywords
Medical Affairs ExperiencePharmacovigilance KnowledgeVendor ManagementRegulatory ComplianceKPI/SLA Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Medical Information OperationsAdverse Event IntakeScientific Response Letter FulfillmentRegulatory Reporting RequirementsGovernance Frameworks
Soft Skills
Operational OversightPerformance ManagementTraining and Development
Industry Keywords
GVPGCPPharmaceutical IndustryBiotechnology IndustryContact Center Management
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Serve as the primary business owner and day-to-day point of contact for the company's outsourced Medical Information Contact Center (MICC) vendor.
- Responsible for operational oversight, governance, and performance management of the vendor relationship.
- Ensure that medical inquiries, scientific response letter (SRL) fulfillment, adverse event (AE) intake, and product quality complaint (PQC) intake are handled accurately and compliantly.
- Monitor vendor performance against contractual key performance indicators (KPIs) and service level agreements (SLAs).
- Oversee onboarding, ongoing training, and product/process knowledge transfer for vendor staff.
- Ensure accurate recognition, documentation, and timely transfer of adverse event (AE) reports to the Pharmacovigilance/Safety function.
Requirements
What you’ll need- Bachelor's degree in a scientific, healthcare, or related discipline
- Minimum of 5–7 years of experience in Medical Affairs, Medical Information, and/or Pharmacovigilance within the pharmaceutical or biotechnology industry.
- Demonstrated working knowledge of both Medical Information operations (inquiry handling, SRL fulfillment) and Pharmacovigilance processes (AE intake, reconciliation, regulatory reporting requirements).
- Experience managing or overseeing outsourced vendors, CROs, or contact center service providers, including governance and KPI/SLA management.
- Solid understanding of relevant regulatory and compliance frameworks, including GVP, GCP, and the required separation of Medical and Commercial activities.
Benefits
Comp & perks- medical
- dental
- vision
- time off
- 401K
- participating in Mineralys incentive plans are contingent on achievement of personal and company performance