Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.

Responsible for providing input into the strategic and proactive direction of safety and pharmacovigilance operational activities for all Acadia products. Responsible for the management of PV vendor(s) to ensure state of compliance. Acts as the Acadia Safety Operations Lead for Acadia clinical programs. Collaborates with the Safety Physician to provide necessary information for the identification and investigation of potential safety signals and contribute to the development of risk management and pharmacovigilance plans. Ensures compliance with timely reporting of the adverse events that meet regulatory requirements for submissions to the applicable Regulatory Agencies.

Primary Responsibilities

• Participates in setting the strategic direction of PV operational activities to ensure a cost-effective and scalable PV system in place.
• Provides oversight of safety information processing, reconciliation and reporting by outsourced vendors, including the review of Individual Case Safety Reports (ICSR), and review of case processing metrics.
• Management of aggregate reports, including Development Safety Update Report (DSUR).
• Participates in the development and management of the Pharmacovigilance System Master File (PSMF).
• Liaises with DSP Quality Standards and Training (QST) in the review of Key performance Indicators (KPIs) including case quality, reporting and workflow metrics to assess vendor performance and takes appropriate action.
• Liaises cross functionally to ensure needed PV requirements are in contracts of other vendors in receipt of safety information. (e.g. Commercial) and ensures appropriate procedures and processes are in place for the receipt and reconciliation of such information.
• Monitors global regulatory intelligence to ensure DSP requirements with safety reporting
• Liaises with global teams on execution of deliverables, such as study deliverables, aggregate reporting, and post marketing activities.
• Assists in management of budgets (internal/external).
• Acts as safety lead for various ACADIA studies to ensure all PV activities are complete and compliant.
• In collaboration with Regulatory Affairs and/or Contract Service Provider, ensures timely submission of expedited and aggregate safety reports to Regulatory Authorities.
• Develops, reviews and updates drug safety forms and templates, and harmonization with relevant clinical operation forms and templates (i.e. SAE data collection form, PADER template etc.).
• Participates in the management of safety data exchange agreements with business partners if required.
• Participates in strategic planning, workflow development, audits and regulatory inspections.
• Updates key documents including Safety Management Plans, Vendor Oversight Plans, Safety Reporting Forms, narratives and AOSE templates, and other safety related documentation as needed
• Ensures training of appropriate cross-functional personnel and external groups in drug safety principles and practices.
• Identifies and develops process improvement strategies and communicate project status updates.
• Ensures compliance with global regulations and ICH guidelines to meet all regulatory drug safety and pharmacovigilance reporting requirements.
• Other duties as assigned.

Education/Experience/Skills

Bachelor's degree in life sciences or related field. Targeting 10 years of progressively experience in the pharmaceutical or biotech industry with 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.

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business needs.

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