Executive Director Drug Safety and Pharmacovigilance

Position Summary

In this role, this individual will be responsible for overseeing all aspects of product safety across clinical development and post-marketing surveillance.  They will support the overall strategy and approaches within Medical Safety and support the PV team on scientific topics. This key leadership role ensures that pharmacovigilance (PV) activities align with regulatory requirements and company standards, and drives the strategy and execution of safety science to protect patient health and optimize product benefit-risk profiles.

Primary Responsibilities

• Develop strategies, working with the Head of Safety, to achieve PV Medical Safety goals.
• Along with the Head of Safety, represent PV in communications with health authorities such as the Food and Drug Administration (FDA).
• Assess safety signals and trends and proactively manage any potential safety issues.
• Formulate response strategies and author responses for health authority requests.
• Determine the need for pharmacoepidemiology, including input and liaising with external pharmacoepidemiologists.
• Ensure PV Medical Safety activities are performed in compliance with all applicable regulations and Acadia standards.
• Assist with oversight of the vendor performing medical review of Individual Case Safety Report (ICSR) and aggregate report on behalf of Acadia.
• Perform medical review of serious adverse events from Acadia clinical trials.
• Accountable for medical evaluation / interpretation of aggregate safety data of assigned product(s), including signal detection and evaluation, and ad hoc safety assessments.
• Provide oversight for the safety aspects of clinical studies, and development and maintenance of Acadias core safety information.
• Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, annual reports (DSUR), final study reports, and other documents as needed.
• Lead development of Risk Management Plans, implementation and evaluation of their effectiveness.
• Ensure safety issues are communicated to the appropriate stakeholders in a timely fashion.
• Author Analysis of Similar Events (AOSE) and individual case comments for ICSRs.
• Maintain knowledge of global regulatory authority regulations, including the FDA and European Medicines Agency (EMA).
• Contribute to the training, leadership and continuing education of department staff.
• Perform other duties as assigned.

Education / Experience / Skills

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

$1 — $2 USD

What we offer US-based Employees :

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.