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Acadia Pharmaceuticals Inc. · 6 hours ago

Manager, Drug Safety & Pharmacovigilance Operations

San Diego, CA

Full-time

Hybrid

Mid, Senior Level

$107K/yr - $134K/yr

5+ years exp

Acadia Pharmaceuticals is dedicated to innovating treatments for underserved neurological and rare disease communities globally. The Pharmacovigilance Operations Manager is responsible for overseeing patient safety and operational excellence in clinical development, ensuring compliance and quality in safety data management.

BiotechnologyHealth CarePharmaceutical

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

Qualification

PharmacovigilanceICSR managementRegulatory complianceDSUR knowledgeMedDRA knowledgeProject managementMicrosoft WordMicrosoft ExcelInterpersonal skillsOrganizational skillsCommunication skillsAdaptabilityNegotiation skills

Required

Bachelor's degree in nursing, pharmacy or related field

Targeting 5 years of progressive experience in the pharmaceutical or biotech industry with the majority in Pharmacovigilance

Must have knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments (including ICH/CIOMS, Clinical development methodology and knowledge of Clinical Trial guidelines (GCP) and regulation)

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 common safety database (ARGUS or ARISg)

Demonstrated technical, administrative, and project management capabilities

Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills

Adaptable to changing priorities

Proven ability to manage through vision setting and constructive feedback

Proficient computer skills, including Microsoft Word and Excel

Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the department or segments of the organization

Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals

Must be able and willing to travel on occasion