Role Summary:The Senior Director, Drug Safety and Pharmacovigilance (DSPV) Operations will provide operational leadership for pharmacovigilance activities, including case management, vendor governance, regulatory compliance, the PV Quality Management System (QMS), inspection and audit readiness, training, and performance metrics. This individual will also oversee DSPV contracts, budgets, and invoices.
Serving as the subject matter expert for outsourced safety operations, the Senior Director will oversee case processing, expedited reporting, and activities related to the Argus global safety database (GSDB), including reporting, business continuity, and disaster-recovery planning.
Responsible for reports preparation and vendor management for GSDB related activities. Serves as lead for PV compliance, QMS, and inspection /audit readiness for the DSPV function, and for the organization and oversight of the Safety Management Plans (SMP), Safety Management Team (SMT) meetings, Vendor Oversight Plan (VOP).
As the case management lead, the Senior Director will monitor case-processing activities performed by patient support programs (PSPs), vendors, and business partners. This individual will ensure compliance with applicable study protocols, SMPs, VOPs, SOPs, work instructions (WIs), study plans, contractual obligations, and established key performance indicators (KPIs).
This position reports to the Senior Vice President, Drug Safety and Pharmacovigilance.
Key Responsibilities:Case Management and Safety Systems- Provide oversight of end-to-end case processing for clinical development programs, ensuring timely, accurate, and compliant collection, review, processing, follow-up, reconciliation, and reporting of safety information.
- Serve as the operational subject matter expert and lead for the Argus global safety database, including workflows, vendor activities, data outputs, reporting, system compliance, and applicable business-continuity and disaster-recovery processes.
- Oversee expedited safety reporting, including SUSAR submissions, in accordance with applicable regulatory requirements and timelines.
- Establish and monitor case-processing workflows, KPIs, compliance metrics, and operational deliverables; review and escalate performance issues and trends.
- Monitor safety operations performed by PSPs, vendors, and business partners for compliance with protocols, SMPs, VOPs, SOPs, work instructions, study plans, contracts, and applicable regulations.
- Serve as the unblinded Drug Safety Operations representative, as required.
Vendor and Operational Governance- Provide operational leadership and oversight of DSPV vendors, service providers, consultants, and business partners, including clear definition of roles, responsibilities, deliverables, and escalation pathways.
- Lead or participate in SMTs, vendor governance meetings, cross-functional program teams, and other safety governance forums; track actions, risks, issues, and escalations through resolution.
- Develop and maintain operational plans, SOPs, work instructions, workflows, and other DSPV processes in collaboration with internal stakeholders and external providers.
- Oversee SMPs and VOPs and ensure their implementation across applicable programs and vendors.
- Manage DSPV vendor and consultant budgets, contracts, statements of work, change orders, and invoices.
Safety Data, Surveillance, and Reporting- Oversee safety-data reconciliation with Data Management, Clinical CROs, and other stakeholders and ensure timely resolution of discrepancies.
- Collaborate with Safety Physicians, Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and external vendors on safety-data review, analysis, reporting, iDMC, and surveillance.
- Prepare and oversee safety reports, listings, narratives, and other data outputs supporting risk management, regulatory submissions, and safety governance.
- Support identification and evaluation of emerging safety concerns
- Support preparation and review of health authority responses and aggregate and expedited safety reports, including DSURs, and 6M line listings.
- Support safety-related sections of CSRs and other clinical documents and provide safety-data outputs for independent Data Monitoring committee meetings.
- Support the Senior Vice President, DSPV, in preparation and facilitation of safety governance and Safety Advisory Committee meetings.
Quality, Compliance, and Inspection Readiness- Under the direction of the Senior Vice President, DSPV, and in partnership with Quality Assurance, oversee and continuously improve the DSPV QMS.
- Maintain audit and inspection readiness for DSPV activities, systems, vendors, and business partners.
- Lead or coordinate DSPV preparation for internal and external audits and regulatory inspections.
- Oversee CAPAs, remediation activities, and compliance improvements related to DSPV operations.
- Serve as the DSPV subject matter expert for PV compliance and inspection-readiness matters involving case management, safety systems, reporting, workflows, documentation, and KPIs.
Systems, Documentation, and Business Continuity- Oversee the organization, completeness, and maintenance of DSPV documentation within SharePoint and applicable electronic trial master file systems.
- Partner with IT and relevant vendors to maintain appropriate data-security, data-protection, access, and system-continuity processes for the GSDB and related systems.
- Develop, maintain, and periodically test DSPV business-continuity and disaster-recovery plans for critical systems and operations.
Training- Lead development and maintenance of the DSPV training curriculum and ensure training requirements support applicable SOPs, processes, systems, and regulatory expectations.
- Oversee vendor training programs and monitor training completion and compliance.
Other- Perform other duties as assigned.
Ideal Candidate:- Master's degree in relevant field (Life sciences) or equivalent combination of education and experience; nursing degree (RN) or pharmacy degree (PharmD) preferred
- Minimum of eight years of experience in pharmacovigilance operations or a related function within the biotechnology or pharmaceutical industry.
- Hands-on experience with global safety databases, preferably Argus, and safety-data analytics.
- Demonstrated experience with case processing, safety-database oversight, vendor governance, audit and inspection readiness, and budget and invoice management.
- Experience managing and providing oversight of pharmacovigilance service providers and safety-database hosting partners.
- Strong knowledge of ICH guidelines and applicable U.S. and European pharmacovigilance regulations and requirements.
- Experience preparing safety-data outputs for aggregate and periodic safety reports (DSUR, 6MLLs).
- Excellent analytical and problem-solving skills, with the ability to interpret complex data and translate findings into actionable drug development strategies
- Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions
What We Offer:- Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- Unlimited PTO
- Two, one-week company-wide shutdowns each
- Commitment to provide professional development opportunities.
- Remote working environment with frequent in-person meetings to address complex problems and build relationships.
The expected salary range offer for this role is $295,000 to $311,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
