Job description
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 neuro-psychiatric and neuro-rare diseases. For more information, visit Acadia.com and follow us on LinkedIn and X.
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 Acadia’s 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
- MD degree or equivalent with clinical post-training resulting in eligibility for a US medical board certification.
- Experience in pharmacovigilance, preferably in a pharmaceutical or biotechnology company with experience in signal management (e.g., signal detection, evaluation, ICSRs, etc.).
- MPH or pharmacoepidemiology expertise desired.
- Neurology, psychiatry, Rare, and CNS-related disease experience preferred.
- Sr. Director level: Targeting 10+ years of relevant drug safety experience in the biotechnology/pharmaceutical industry, including safety leadership experience.
- Executive Director level: Targeting 15+ years of relevant drug safety experience in the biotechnology/pharmaceutical industry, including safety leadership experience.
- Solid knowledge of and experience with FDA and EU regulations and ICH guidelines related to pharmacovigilance, including safety monitoring and reporting in clinical trials, post-marketing surveillance, case processing, safety agreement requirements, and reporting to Health Authorities worldwide.
- Advanced ability to assess product risk-benefit profiles and interpret post-market safety data.
- Responds appropriately to rapidly changing regulatory environment with minimal oversight.
- Works collaboratively and effectively with colleagues across Acadia to contribute to meeting organizational goals and objectives.
- Ability to assess evolving regulatory landscape, weigh possible courses of action, provide advice, and make sound decisions.
- Strong attention to detail in establishing priorities, scheduling, and meeting deadlines.
- Ability to work independently, take initiative, and complete tasks to deadlines.
- Excellent interpersonal, communication, analytical, and organizational skills.
- Demonstrated ability to motivate, lead, and train others.
- Proficient computer skills, including Microsoft Word, PowerPoint and Excel.
- Must be able to travel domestically and internationally 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-HYBRID #LI-MS1
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:
- 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 [email protected] 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 seeAdditional 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.
