Associate Director/Director, Medical Information & Pharmacovigilance Contact Center Operations

“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone.  Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor.  Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com . Follow Mineralys on LinkedIn, Twitter and Bluesky”

Mineralys is a fully remote company.

Associate Director/Director, Medical Information & Pharmacovigilance Contact Center Operations

The Associate Director/Director, Medical Information & Pharmacovigilance Contact Center Operations serves as the primary business owner and day-to-day point of contact for the company's outsourced Medical Information Contact Center (MICC) vendor. This role is responsible for the operational oversight, governance, and performance management of the vendor relationship, ensuring that medical inquiries, scientific response letter (SRL) fulfillment, adverse event (AE) intake, and product quality complaint (PQC) intake are handled accurately, compliantly, and within agreed service levels. The position requires a unique combination of Medical Information and Pharmacovigilance knowledge to bridge Medical Affairs, Pharmacovigilance/Safety, Quality and IT call center functions to ensure a seamless, inspection-ready contact center operation in support of commercial launch.

Key Responsibilities

Vendor Oversight & Governance

Act as the primary business owner and day-to-day liaison for the outsourced Medical Information Contact Center vendor, managing the operational relationship across the full scope of services. Lead regular governance meetings with the vendor, tracking action items, escalations, deliverables, and continuous improvement initiatives.

Monitor vendor performance against contractual key performance indicators (KPIs) and service level agreements (SLAs), proactively identifying and resolving gaps in quality or timeliness.

Oversee onboarding, ongoing training, and product/process knowledge transfer for vendor staff, ensuring alignment with company-specific requirements.

Coordinate change orders, scope adjustments, and budget tracking in partnership with Vendor Management and Finance as call volumes and program needs evolve.

Serve as the central point of contact connecting the contact center vendor with the separate Pharmacovigilance/Safety vendor to ensure a coordinated, closed-loop cross-vendor workflow.

Manage the distribution of vendor-generated activity reporting and metrics to key internal stakeholders, ensuring timely and accurate communication.

Medical Information Operations

Oversee end-to-end medical inquiry intake, triage, documentation, and fulfillment for healthcare professionals (HCPs) and consumers received via phone, email, and other channels.

Manage the Scientific Response Letter (SRL) fulfillment process, including the intake and handling of Medical Information Request Forms (MIRFs) submitted by Medical Science Liaisons (MSLs), ensuring timely status updates, version and document control, and a closed-loop communication process that provides visibility back to the original requestor.

Define and maintain Tier 1 (standard/basic) versus Tier 2 (complex) inquiry handling and clear escalation pathways into the internal Medical Affairs team.

Partner with Scientific/Medical Communications to ensure approved response documents, standard response letters, and publications are current and accessible to the vendor.

Support development and maintenance of the Medical Information SOP, FAQs, standard or custom response letters and MI fulfillment training materials. Pharmacovigilance & Safety Intake

Ensure the vendor's accurate recognition, documentation, and timely transfer of adverse event (AE) reports to the Pharmacovigilance/Safety function in accordance with agreed timelines and regulatory requirements.

Oversee the secure end-to-end transfer of call center safety data to PV for case processing and regulatory reporting, including reconciliation processes to confirm receipt of each case.

Coordinate the intake and routing of product quality complaints (PQCs), including batch/lot traceability capture, with escalation to Mineralys Quality Assurance.

Ensure call center processes support compliant adverse event intake, follow-up activities, and the transfer of information required for downstream PV case processing, MedDRA coding, and regulatory reporting.

Ensure a clear, compliant separation and handoff of responsibilities between contact center intake and downstream PV case processing.

Systems Integration

Partner with IT and the vendor to ensure seamless integration of the contact center workflow with the Med Affairs and Med Info technology stack (e.g. Med Affairs Veeva CRM, MedComms, PromoMats), including MIRF routing and close-loop case completion.

Ensure Pharmacovigilance system workflows are integrated with the call center workflows.

Coordinate system and integration testing with call center provider and Mineralys resources.

Systems Integration

Compliance, Quality & Reporting

Ensure all contact center activities are conducted in a compliant, inspection-ready manner consistent with GVP, GCP, GMP, applicable regulatory requirements, and internal SOPs.

Maintain a strict separation between Medical and Commercial activities and information in all reporting and documentation.

Support vendor audits and internal, client, and regulatory inspections, including readiness activities and CAPA follow-up.

Develop and deliver routine performance reporting and executive summaries on contact center metrics, inquiry trends, and safety reconciliation for leadership review.

Maintain and continuously improve program-specific procedural documents, governing documents, and quality monitoring plans in collaboration with Quality.

Qualifications

Bachelor's degree in a scientific, healthcare, or related discipline; advanced degree (PharmD, PhD, MS, RN, or RPh) strongly preferred.

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.

Preferred Qualifications

Hands-on experience with Veeva CRM and Veeva Vault (MedComms and PromoMats), including MIRF and SRL workflows.

Experience supporting a product launch or standing up a medical information / safety contact center at a small or emerging biopharmaceutical company.

Familiarity with safety databases (e.g., Argus) and case data exchange standards (e.g., E2B), MedDRA, and WHO Drug coding.

Experience developing SOPs, training materials, and quality monitoring plans for field medical or contact center operations.

Core Competencies

Strong vendor and relationship management skills with the ability to hold partners accountable while fostering collaboration.

Excellent cross-functional communication and stakeholder alignment across Medical Affairs, PV, Quality, IT, and Commercial.

Detail-oriented with a strong commitment to compliance, accuracy, and data integrity.

Ability to manage multiple competing priorities and deliverables under tight timelines.

Sound judgment and a proactive, problem-solving mindset in a fast-paced, pre-commercial environment.

Travel

Domestic travel of up to 20% may be required to support company meetings, cross-functional planning sessions, vendor meetings, training, and other business activities.

This position is eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level.

US Salary Range:  $125,000 - $185,000

#LI-Remote