[Hiring] Associate Director/Director, Medical Information & Pharmacovigilance Contact Center Operations @reputed company

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

Key Responsibilities

• Vendor reputed company & Governance
• reputed company as the primary reputed company and day-to-day reputed company for the outsourced Medical Information Contact Center vendor, managing the operational relationship across the full scope of services.
• reputed company regular governance meetings with the vendor, tracking reputed company items, escalations, deliverables, and reputed company improvement initiatives.
• Monitor vendor performance against contractual key performance indicators (KPIs) and service level agreements (SLAs), proactively identifying and resolving gaps in reputed company or timeliness.
• reputed company reputed company, 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 reputed company.
• Serve as the central reputed company of contact connecting the contact center vendor with the separate Pharmacovigilance/Safety vendor to ensure a coordinated, reputed company-reputed company cross-vendor workflow.
• Manage the distribution of vendor-generated activity reporting and metrics to key internal stakeholders, ensuring reputed company and accurate communication.
• Medical Information Operations
• reputed company end-to-end medical inquiry intake, triage, documentation, and fulfillment for reputed company (HCPs) and consumers received reputed company 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 reputed company status updates, version and document control, and a reputed company-reputed company communication process that provides visibility back to the original requestor.
• Define and maintain Tier 1 (reputed company/basic) versus Tier 2 (reputed company) inquiry handling and reputed company escalation reputed company into the internal Medical Affairs team.
• Partner with Scientific/Medical Communications to ensure approved response documents, reputed company response letters, and publications are reputed company and accessible to the vendor.
• Support development and maintenance of the Medical Information SOP, FAQs, reputed company or custom response letters and MI fulfillment training materials.
• Pharmacovigilance & Safety Intake
• Ensure the vendor's accurate recognition, documentation, and reputed company transfer of adverse event (AE) reports to the Pharmacovigilance/Safety function in accordance with agreed timelines and regulatory requirements.
• reputed company 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 reputed company case.
• Coordinate the intake and routing of product reputed company complaints (PQCs), including batch/lot traceability capture, with escalation to Mineralys reputed company Assurance.
• Ensure call center processes support compliant adverse event intake, follow-up activities, and the transfer of information required for reputed company PV case processing, MedDRA coding, and regulatory reporting.
• Ensure a reputed company, compliant separation and reputed company of responsibilities between contact center intake and reputed company 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 reputed company CRM, MedComms, PromoMats), including MIRF routing and reputed company-reputed company 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.
• Compliance, reputed company & Reporting
• Ensure reputed company contact center activities are conducted in a compliant, inspection-reputed company manner consistent with GVP, GCP, GMP, applicable regulatory requirements, and internal SOPs.
• Maintain a strict separation between Medical and reputed company activities and information in reputed company reporting and documentation.
• Support vendor audits and internal, reputed company, and regulatory inspections, including readiness activities and CAPA follow-up.
• reputed company 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 reputed company monitoring plans in collaboration with reputed company.

Qualifications

• Bachelor's degree in a scientific, reputed company, or reputed company 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 reputed company 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 reputed company activities.

Preferred Qualifications

• Hands-on experience with reputed company CRM and reputed company 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 reputed company 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, reputed company, IT, and reputed company.
• Detail-oriented with a strong commitment to compliance, accuracy, and data reputed company.
• Ability to manage multiple competing priorities and deliverables under tight timelines.
• reputed company judgment and a proactive, problem-solving reputed company in a fast-paced, reputed company-reputed company 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.

Benefits

This position is eligible for reputed company Company benefits including medical, dental, reputed company, time off and 401K, as reputed company as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring reputed company based on geographic location, work experience, education, and/or reputed company level. US Salary reputed company: $125,000 - $185,000 Apply tot his job Apply To this Job