Location of role Gaithersburg, MD, Radnor, PA, Oxford, UK
Department Regulatory Affairs
The Associate Director, Safety Operations is a key operational leader responsible for the execution and management of global pharmacovigilance operations. Reporting to the Director of PV Operations, the Associate Director ensures the seamless delivery of case management, regulatory reporting, and operational compliance across clinical and post‑marketing portfolios.
This role serves as the primary operational interface for PV vendors and cross‑functional study teams. The Associate Director is an emerging expert who translates the functional strategy into actionable operational plans, manages complex technical issues with limited guidance, and ensures that the "hands‑on" elements of the PV system are robust, scalable, and inspection‑ready.
KEY RESPONSIBILITIES
* Lead the day‑to‑day execution of global safety operations, ensuring all ICSRs (clinical and post‑marketing) are processed, quality‑checked, and submitted within strict regulatory timelines.
* Act as the primary point of escalation for complex case‑processing issues, providing technical guidance to internal staff and vendors.
* Manage the operational "rhythm" of the department, including SAE reconciliation, literature surveillance workflows, and safety query management.
* Drive the day‑to‑day oversight of PV vendors/CROs; monitor performance against SLAs and KPIs, and lead regular operational governance meetings.
* Identify vendor performance trends and implement immediate corrective actions or process improvements to maintain compliance.
* Support the vendor selection and contract/SOW scoping by providing detailed operational requirements.
* Serve as the Operational SME during audits and Health Authority inspections; prepare "storyboards," collate evidence of oversight, and manage the logistics of operational document requests.
* Lead the drafting and maintenance of operational SOPs, Work Instructions, and Safety Management Plans, ensuring they reflect current "best practices" and regulatory requirements.
* Monitor PV compliance metrics (e.g., late reporting rates) and lead the investigation and documentation of deviations/CAPAs.
* Represent PV Operations on Clinical Study Teams; provide expert input on CRF design, safety reporting sections of protocols, and Investigator Brochure (IB) updates.
* Ensure the successful implementation of Safety Data Exchange Agreements (SDEAs) at the operational level, ensuring all data‑sharing triggers are met.
* Partner with Safety Systems/IT to manage the operational configuration and user‑acceptance testing (UAT) for safety database enhancements.
* Ensure high‑quality safety data is available for the Safety Physicians to perform signal detection and aggregate reporting (DSURs, PSURs/PBRERs).
COMPETENCIES
* Recognized as an emerging expert in PV Ops; applies broad expertise to achieve goals in creative ways; has a clear understanding of how their work connects to the wider company strategy.
* Works on significant and unique complex issues where problems are not clearly defined; evaluates intangible variables and makes tough operational decisions in a timely manner.
* Develops the strategy for their specific operational area (e.g., case management or vendor oversight) and drives the execution of those plans.
* Ability to influence, negotiate, and persuade on difficult operational concepts.
* Leads functional teams or projects; serves as a best‑practice/quality resource; provides guidance, coaching, and mentorship to professional and managerial employees.
PERSON SPECIFICATION
EXPERIENCE & KNOWLEDGE
* Extensive experience in pharmacovigilance operations, with significant leadership in global ICSR management and regulatory reporting.
* In‑depth knowledge of global PV regulations (GVP, ICH, FDA, MHRA, EMA) and proven ability to implement them operationally.
* Strong experience with safety databases and PV systems, including configuration, validation, and maintenance.
* Demonstrated ability to lead, develop, and manage a team of PV professionals and oversee PV vendors/CROs.
* Proven track record in preparing for and supporting Health Authority inspections and audits, alongside strong project management skills.
* Advanced degree in a relevant scientific or health‑related field.
* Experience with safety data exchange agreements (SDEAs) and literature surveillance.
* Demonstrated ability to drive continuous improvement, process optimization, and automation in PV operations.
* Familiarity with operational support for Risk Management Plans (RMPs) and aggregate safety reports.
* Demonstrated understanding of clinical development processes.
* Experience with global product launches and implementation/assessment of complex risk minimisation measures.
* Evidence of scientific contributions to the field (e.g., peer reviewed publications, invited presentations, guideline development, or recognised subject matter expertise in biologic safety).
EDUCATION & QUALIFICATIONS
* Bachelor’s degree in life science, pharmacy, nursing, or related health field.
* Proven track record of managing external PV vendors and leading cross‑functional projects.
* Excellent communication skills, with the ability to influence stakeholders and lead high‑profile meetings.
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