What are the responsibilities and job description for the Sr. Director Drug Safety & PV Quality Standards & Training position at Acadia Pharmaceuticals Inc.?
About Acadia Pharmaceuticals
Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis, and multiple other programs targeting neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at Acadia.com and follow us on LinkedIn and X.
Position Summary
The Sr. Director of Pharmacovigilance Quality Standards and Training is responsible for designing, implementing, and maintaining robust quality systems, standards, and training programs that ensure compliance with global pharmacovigilance (PV) regulations. This role provides strategic leadership to advance PV quality frameworks and capabilities while fostering a culture of continuous improvement and inspection readiness.The ideal candidate is a seasoned pharmacovigilance professional with a proven ability to lead cross-functional initiatives, develop efficient quality standards, and manage training programs across a global organization. They will collaborate with internal stakeholders and external partners to drive excellence in pharmacovigilance compliance.
Primary Responsibilities
Leads and drives business process initiatives to achieve goals in accordance with established policies. Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives. Establishes strategic plans for designated function(s). Meets schedules and overcome challenges; provide direction to and review of resources and personnel across function. Works on abstract problems that may cut across-functional areas and require cross-functional input. Interacts with management on matters of importance. Erroneous decisions will have a serious impact on the overall success of functional area and may impact overall of the Company.
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.
EEO Statement (US-Based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply – especially if the reason you are the best candidate isn’t exactly as we describe it here.
It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.
As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at talentacquisition@acadia-pharm.com or 858-261-2923.
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
Notice for California Applicants: Please see our California Applicant Privacy Notice within our Privacy Policy.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in absence of an executed search agreement will not obligate Acadia in any way with the respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.
Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis, and multiple other programs targeting neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at Acadia.com and follow us on LinkedIn and X.
Position Summary
The Sr. Director of Pharmacovigilance Quality Standards and Training is responsible for designing, implementing, and maintaining robust quality systems, standards, and training programs that ensure compliance with global pharmacovigilance (PV) regulations. This role provides strategic leadership to advance PV quality frameworks and capabilities while fostering a culture of continuous improvement and inspection readiness.The ideal candidate is a seasoned pharmacovigilance professional with a proven ability to lead cross-functional initiatives, develop efficient quality standards, and manage training programs across a global organization. They will collaborate with internal stakeholders and external partners to drive excellence in pharmacovigilance compliance.
Primary Responsibilities
- Develop and execute a global pharmacovigilance quality strategy in alignment with company objectives.
- Establish and maintain effective governance for PV quality management systems (QMS).
- Serve as a key PV quality advisor, to ensure regulatory requirements and industry standards are met.
- Define and track key metrics and KPIs to measure the effectiveness of the PV quality program and identify areas for improvement.
- Lead the development, implementation, and oversight of quality standards, including SOPs, guidelines, work instructions, and controlled documentation, to ensure compliance with global PV regulations.
- Establish systems to collect and analyze data related to PV quality activities, including deviations, CAPAs (Corrective and Preventative Actions) and inspection readiness metrics.
- Oversee pharmacovigilance deviations, CAPA management, and root cause analyses to resolve quality issues.
- Liaises with PV Operations and Quality Assurance (QS) during PV inspections and leads the preparation of responses to inspection safety observations. Acts as Point of Contact for QA for internal and external audits including the formulation of corrective actions/preventative actions as identified during the audit.
- Design and implement comprehensive training strategies for PV professionals, cross-functional teams, and external partners.
- Develop training materials that ensure knowledge of PV principles, relevant guidelines (ICH, GVP, FDA, MHRA), and company SOPs.
- Ensure onboarding, periodic training, and role-based competencies are effectively delivered, tracked, and documented.
- Establish metrics to assess the effectiveness of training programs and identify opportunities for improvement.
- Ensures training of all ACADIA employees on responsibilities to report safety information. Liaise with ACADIA stakeholders to ensure all vendors are also properly trained and training documented
- Other duties as assigned.
- Bachelor’s degree in a life science or related field. Advanced degree preferred
- Targeting 12 years of progressively responsible experience in pharmacovigilance within the pharmaceutical or biotech industry
- Ideal candidate will have 5 years of experience in PV quality systems, training, or compliance leadership roles. An equivalent combination of relevant education and experience may be considered
- Strong knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, MHRA, PMDA) and industry best practices (ICH E2E, GVP modules) including safety monitoring and reporting in clinical trials, post-marketing surveillance, case processing, safety agreement requirements and reporting to Health Authorities worldwide
- Experience leading PV quality audits and inspections, including CAPA implementation
- Proficiency in creating and maintaining quality systems, establishing and tracking performance metrics, compliance monitoring, the development and maintenance of SOPs and training programs, and PV systems/databases
- Effective written and verbal communication skills, including the ability to develop clear and concise documentation and training materials
- Proficient in pharmacovigilance databases, quality systems, and training platforms. Experience with Veeva Vault desirable
- Demonstrated ability to drive operational excellence, inspection readiness, and process improvements
- Ability to motivate lead and train others; drive standards and change across functional areas and sites
- Strong attention to detail in establishing priorities, scheduling and meeting deadlines
- Collaborate with internal teams, including Clinical Development, Medical Affairs, Regulatory Affairs, Quality Assurance, and Legal, to ensure alignment of PV quality strategies
- Engage with external vendors and partners to ensure compliance with PV-related contractual agreements
- Monitor and assess emerging regulations and industry trends to proactively enhance PV processes and ensure compliance
- Foster a continuous improvement mindset by identifying process gaps related to PV quality, and training, implementing best practices, and ensuring scalable and efficient workflows
- Lead initiatives to implement innovative solutions such as technology and automation to improve training and quality management systems
Leads and drives business process initiatives to achieve goals in accordance with established policies. Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives. Establishes strategic plans for designated function(s). Meets schedules and overcome challenges; provide direction to and review of resources and personnel across function. Works on abstract problems that may cut across-functional areas and require cross-functional input. Interacts with management on matters of importance. Erroneous decisions will have a serious impact on the overall success of functional area and may impact overall of the Company.
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.
EEO Statement (US-Based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply – especially if the reason you are the best candidate isn’t exactly as we describe it here.
It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.
As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at talentacquisition@acadia-pharm.com or 858-261-2923.
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
Notice for California Applicants: Please see our California Applicant Privacy Notice within our Privacy Policy.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in absence of an executed search agreement will not obligate Acadia in any way with the respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.
