Manager, Drug Safety & Pharmacovigilance Operations at Acadia Pharmaceuticals Inc.

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

03 Mar, 26

Salary

133700.0

Posted On

03 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Knowledge Of Individual Case Safety Reports (ICSR) Management Processes, Extensive Knowledge Of DSUR, Strong Knowledge Of MedDRA, Common Safety Database (ARGUS Or ARISg), Demonstrated Technical, Administrative, And Project Management Capabilities, Strong Interpersonal Skills, Organizational Skills, Workload Planning Skills, Excellent Verbal And Written Communication Skills, Adaptable To Changing Priorities, Proficient Computer Skills, Skilled At Negotiating, Adept At Creating And Communicating A Clear Vision, Ability To Manage Through Vision Setting And Constructive Feedback

Industry

Pharmaceutical Manufacturing

Description

About Acadia Pharmaceuticals Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference. Position 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. 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 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). 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. #LI-SW1 #LI-HYBRID In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location. Salary Range $107,000—$133,700 USD What we offer US-based Employees: Competitive base, bonus, new hire and ongoing equity packages Medical, dental, and vision insurance Employer-paid life, disability, business travel and EAP coverage 401(k) Plan with a fully vested company match 1:1 up to 5% Employee Stock Purchase Plan with a 2-year purchase price lock-in 15+ vacation days 13 -15 paid holidays, including office closure between December 24th and January 1st 10 days of paid sick time Paid parental leave benefit Tuition assistance 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 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 strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe 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 accommodations given if hired. A new request will need to be submitted for any ADA accommodations after starting employment. California Applicants: Please see Additional Information for California Residents within our Privacy Policy. Canadian Applicants: Please see Additional Information for Canadian Residents within our Privacy Policy. Applicants in the European Economic Area, Switzerland, the United Kingdom, and Serbia: Please see Additional Information for Individuals in the European Economic Area, Switzerland, the United Kingdom, and Serbia 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 the absence of an executed search agreement will not obligate Acadia in any way with 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.

Responsibilities

The Pharmacovigilance Operations Manager oversees key PV operational activities, ensuring patient safety and operational excellence across clinical development programs. This role involves leading operational safety planning, supporting the processing of safety cases, and contributing to inspection readiness through documentation practices.