Manager, Drug Safety & Pharmacovigilance Operations

Role Summary

The Pharmacovigilance Operations Manager plays a critical role in ensuring patient safety and operational excellence across Acadia’s global clinical development programs. This position oversees key PV operational activities with a focus on clinical program safety support, vendor oversight, ICSR quality review, and the development and maintenance of essential PV system documentation. As a strategic partner to Clinical Operations, Data Management, and external safety vendors, the Pharmacovigilance Operations Manager ensures that safety data is managed with rigor, accuracy, and full regulatory compliance. This individual will lead operational safety planning for assigned programs, support the timely and high-quality processing of safety cases, and contribute to inspection readiness through strong documentation practices and continuous process improvement.

Responsibilities

• Serve as the PV Operations Lead for assigned clinical programs, acting as the liaison between PV and Clinical Operations, Data Management, and CRO partners.
• Support review and triage of clinical safety data, including SAE reconciliation and safety data clarifications.
• Contribute to Safety Management Plans (SMPs), safety sections of protocols, and operational safety planning.
• Participate in clinical study team meetings, providing updates on PV activities.
• Support day-to-day operational oversight of the case processing vendor, including case intake, workflow management, compliance review.
• Participate in vendor governance activities (e.g., KPI review, quality metrics, deviation tracking).
• Assist in driving process improvements and standardization across vendor-delivered services.
• Document, track, and escalate issues or quality trends to the Senior Director, PV Operations.
• Perform retrospective quality reviews of ICSRs (spontaneous, clinical, literature, solicited) to assess coding accuracy, narrative completeness, data integrity, and regulatory compliance.
• Identify process or quality gaps and contribute to targeted training and CAPA development.
• Maintain inspection-ready documentation to support internal audits and regulatory inspections.
• Support PV Operations team with routine compliance activities, case reconciliation, database oversight, and safety data quality checks.
• Contribute to the development, maintenance, and periodic review of Expected Terms Lists, including:
• Assist with updates to the Pharmacovigilance System Master File (PSMF), ensuring accuracy of system descriptions.
• Support preparation for regulatory inspections by ensuring operational documentation and PSMF-related information is current and accurate.
• Assist with SOP/WI development, updates, and cross-functional PV process harmonization initiatives.
• Participate in safety database enhancement projects, including user acceptance testing (UAT) and workflow optimization.
• Ensure activities are compliant with global regulatory guidelines (FDA, EMA, MHRA, PMDA), ICH E2B, GVP Modules, and clinical trial regulations (e.g., EU CTR).
• Support aggregate safety reporting (DSURs, PADERs) by providing case quality insights and operational inputs.
• Assist with PV training initiatives across vendors and internal teams.
• Other responsibilities as assigned.

Qualifications

• Required: Bachelor‚Äôs degree in nursing, pharmacy or related field; 5 years of progressive experience in the pharmaceutical or biotech industry with the majority in Pharmacovigilance; knowledge of FDA, EU, ICH guidelines governing safety reporting and processing for clinical trial environments (including ICH/CIOMS, GCP).

Skills

• Knowledge of Individual Case Safety Reports (ICSR) management processes including case receipt, case processing, medical review and regulatory submission.
• Extensive knowledge of DSUR.
• Strong knowledge of MedDRA and safety databases (ARGUS or ARISg).
• Demonstrated technical, administrative, and project management capabilities.
• Strong interpersonal, organizational and workload planning skills with excellent verbal and written communication.
• Adaptable to changing priorities; able to manage through vision setting and constructive feedback.
• Proficient in Microsoft Word and Excel.
• Strong negotiation and influencing skills with senior leaders; ability to align resources to achieve goals.
• Willingness to travel on occasion.

Education

• Bachelor‚Äôs degree in nursing, pharmacy or related field.

Additional Requirements

• Must be able and willing to travel on occasion.