June 13th, 2024 Drug Safety

Senior Director Drug Safety and Pharmacovigilance

Princeton, New Jersey, United States

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Please note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Responsible for supporting the overall strategy and approaches within Medical Safety and supporting the PV management on scientific topics, and interacting with Acadia executives/leaders with respect to issues related to benefit/risk.  Responsible for content and quality of Acadia risk communications. 

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 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 liaise 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 ICSRs 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 the company 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, IB 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 FDA and EMA.
  • Contribute to the training, leadership and continuing education of department staff.
  • Other duties as assigned.

Education and Experience

MD degree or equivalent with clinical post-training resulting in eligibility for a US medical board certification.  Targeting 12 years of relevant drug safety experience in the biotechnology/pharmaceutical industry, including safety leadership experience.  MPH or pharmacoepidemiology expertise desired.  Neurology, psychiatry, or CNS-related disease experience preferred.

Key Skills:

  • Highly-developed scientific and analytical knowledge base and an excellent understanding of good pharmacovigilance practices and current regulations within drug safety.
  • Proficiency at creating and communicating a clear vision and activities to achieve functional area and/or organizational goals.
  • Strength in analysis, critical decision-making and bottom line accountability.
  • Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA.
  • Thorough understanding of U.S. pharmacovigilance regulations, GCP and International Conference on Harmonization (ICH) guidelines.
  • Extensive experience in authoring of all types of aggregate safety reports including setting a strategy to address potential safety issues.
  • In-depth understanding of the drug development process.
  • Extensive experience in partnering with vendors to achieve results.
  • Exceptional written and verbal communication skills.
  • Skilled at negotiating with business partners or managing and influencing senior level leaders regarding matters of significance to the organization.
  • Ability to think strategically at the executive level, implement change, incorporate innovation, and implement strategies throughout all levels of the organization.
  • Ability to build and sustain trusted relationships both internally and externally.
  • Proficient computer skills, including Argus, Microsoft Word, PowerPoint and Excel.

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.  Ability to travel independently overnight and work after hours if required by travel schedule or business needs.

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What we offer you (US-Based Employees):

  • Competitive base, bonus, new hire and ongoing equity packages
  • Medical, dental, and vision insurance
  • 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
  • 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
  • 10 days of paid sick time
  • Paid parental leave
  • 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 single 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 would strongly encourage you to apply – especially if the reason you are the best candidate isn’t exactly as we describe it 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 accommodation 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 absence of an executed search agreement will not obligate Acadia in any way with the 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.