Senior Medical Safety Scientist

Primary Responsibilities

• Serve as the scientific safety lead for assigned products, providing pharmacovigilance expertise across clinical development and post-marketing activities
• Conduct routine and ad hoc review of safety data from clinical trials, post-marketing sources, literature, business partners, and other relevant sources to support ongoing safety surveillance
• Lead signal detection, validation, evaluation, tracking, and aggregate safety analyses, including review of case series, adverse event trends, data mining outputs, and benefit-risk assessments
• Author and maintain key safety deliverables including signal assessments, safety evaluations, benefit-risk assessments, safety narratives, AOSEs, Safety Surveillance Plans (SSPs), and signal management documentation
• Support aggregate safety reports, regulatory submissions, health authority responses, core safety information, Risk Management Plans (RMPs), REMS activities, and other product risk management initiatives
• Provide scientific safety expertise to governance committees and cross-functional teams, including Clinical Development, Regulatory Affairs, Biostatistics, Medical Writing, Epidemiology, Medical Affairs, and Quality
• Review safety listings, line listings, adverse event summaries, and retrospective safety data analyses to identify and evaluate emerging safety concerns and risks
• Support audits, inspections, and regulatory authority inspections by ensuring safety documentation is accurate, complete, and inspection ready while maintaining compliance with global pharmacovigilance regulations and Good Pharmacovigilance Practices (GVP)
• Maintain current knowledge of safety science methodologies, signal management practices, and evolving global regulatory requirements
• Other duties as assigned

Education/Experience/Skills

• PharmD, PhD, MS, MSN, MPH, RN, NP, PA, or equivalent degree from an accredited institution
• 7+ years of experience in drug safety, pharmacovigilance, clinical safety, or risk management within the pharmaceutical or biotechnology industry
• Experience in safety surveillance, signal detection and management, aggregate safety data review, benefit-risk assessment, and product safety evaluation
• Experience authoring regulatory safety documents including signal assessments, DSURs, PBRERs, safety sections of clinical documents, aggregate reports, and health authority responses
• Advanced knowledge of FDA, EU, and ICH regulations and guidelines related to pharmacovigilance, clinical trial safety monitoring, signal management, aggregate reporting, and post-marketing surveillance
• Expertise in safety signal detection, validation, evaluation, and risk assessment methodologies
• Experience with pharmacovigilance databases and safety systems, including Argus Safety, as well as signal detection tools
• Strong knowledge of MedDRA coding conventions, safety data review methodologies, and adverse event analysis
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
• Ability to travel domestically and internationally as required

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.

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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.