Manager, Drug Safety & Pharmacovigilance Operations

Position Summary

The Pharmacovigilance Operations Manager plays a critical role in ensuring patient safety and operational excellence across Acadias 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.

This role is ideal for a PV professional who thrives in a collaborative matrix environment enjoys solving operational challenges and is motivated by the responsibility of upholding the highest standards of global patient safety.

Primary 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.

Education/Experience/Skills

Bachelors 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). An equivalent combination of relevant education and experience may be considered.

Key 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 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.

Physical Requirements

This role involves regular standing walking sitting and the use of hands for handling or operating equipment. The employee may also need to reach climb balance stoop kneel crouch and maintain visual verbal and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

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Required Experience:

Manager