Manager, Drug Safety & Pharmacovigilance

Position Summary

The Pharmacovigilance (PV) Systems Manager will serve as the primary owner and subject matter expert for Acadias Argus Safety Database, ensuring the system is secure, compliant, and optimized to support global safety operations. This critical role combines technical expertise, vendor management, and regulatory knowledge to maintain the integrity of safety data, enable efficient reporting, and support pharmacovigilance and regulatory submission activities.

The PV Systems Manager will lead all aspects of system oversight from daily operations and helpdesk support to vendor governance, upgrades, validation, and reporting. This individual will collaborate cross-functionally with IT, Quality, Clinical, and Regulatory teams to ensure seamless safety system performance, data integrity, and audit readiness. The role requires strong project management skills, deep understanding of PV workflows and regulations, and the ability to translate business needs into system solutions.

As the Argus Safety Database owner, this position is central to ensuring that Acadia remains compliant with evolving global pharmacovigilance regulations while enabling proactive safety surveillance that ultimately protects patients.

Primary Responsibilities

Execution of weekly, monthly and ad hoc reports from the PV database.

Serve as the primary system owner for the Argus Safety Database, overseeing its configuration, maintenance, and performance.

Manage the safety database hosting vendor, including service-level agreements (SLAs), issue resolution, change control, and compliance.

Oversee the PV systems helpdesk and ensure timely resolution of user issues and support requests.

Coordinate system upgrades, validation activities, and patch releases in collaboration with IT, Quality Assurance (QA), and the hosting vendor.

Develop and maintain system documentation, including user guides, Standard Operating Procedures (SOP), and configuration specifications.

Design, generate, and validate routine and ad hoc reports to support regulatory reporting, signal detection, and safety surveillance activities.

Collaborate cross-functionally across departments and external stakeholders to ensure compliance with global regulatory requirements (e.g., FDA, EMA, MHRA, PMDA).

Monitor and enforce user access controls, data security protocols, and audit readiness.

Provide system training and onboarding support for Argus users.

Represent PV Systems in audits, inspections, and cross-functional initiatives.

Perform other duties as assigned.

Education / Experience / Skills

Bachelors degree in Life Sciences, Information Technology, or a related field.  Targeting 5 years of progressively responsible experience in pharmacovigilance, with at least 2 years managing Argus Safety or similar safety databases.  An equivalent combination of relevant education and experience may be considered.

Key Skills :

Experience managing external vendors and service providers.

Strong knowledge of global pharmacovigilance regulatory requirements and ICH guidelines.

Proficiency in safety database reporting tools (e.g., Argus Insight, SQL, OBIEE, Cognos).

Understanding of system validation (CSV), change management, and audit readiness.

Excellent analytical reasoning and problem-solving capabilities with the ability to solve problems.

Excellent interpersonal and collaborative skills, with a professional demeanor, with the ability to interact with colleagues, cross-functional partners and vendors.

Strong organizational and time management skills with the ability to multitask & prioritize own efforts.

Must be able to travel domestically 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.

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 — $133,000 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 isnt 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 Acadias 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.

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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.