For the safety of our employees and communities in response to COVID-19, ACADIA has implemented a temporary work from home policy. As a part of this shift, we have migrated all interviews to virtual interviewing via phone and video.

Position Summary:

Responsible for defining overall strategy and approaches within Medical Safety, including leading a Safety Management Team, supporting the VP of PV 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 SVP of PV, to achieve PV Medical Safety goals.
  • Along with the Corporate Safety Officer, represent PV in communications with health authorities such as the FDA.
  • Oversee and approve contributions of Medical Safety team with respect to study protocols, Investigator Brochures, and other safety-related documents / communications.
  • Ensure the ongoing performance of signal management activities.
  • Assess safety signals and trends and proactively manage any potential safety issues.
  • Lead the Safety Management Team and communicate, as appropriate, to ACADIA management.
  • Formulate response strategies for health authority requests.
  • Determine need for pharmacoepidemoiology input and liaise with external pharmacoepidemiologist.
  • Ensure PV Medical Safety activities are performed in compliance with all applicable regulations and ACADIA standards.
  • Perform medical review of ICSRs for assigned product(s).
  • Accountable for medical evaluation/interpretation of aggregate safety data of assigned product(s) including signal detection and evaluation, regulatory safety reports (PADER, PBRER/PSUR) and ad hoc safety assessments.
  • Provide oversight for the safety aspects for 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 for department staff.
  • Other duties as assigned.

Education/Experience/Skills:

  • MD degree or equivalent with clinical post-training resulting in eligibility for a US medical board certification.
  • MPH or pharmacoepidemiology expertise a plus.
  • A minimum of 15 years of relevant drug safety experience in the biotechnology/pharmaceutical industry, including a minimum of 10 years of safety leadership experience.
  • Neurology, psychiatry, or CNS-related disease experience a plus.
  • 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 among team members and effectively aligning resources 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 Harmonisation (ICH) guidelines.
  • Extensive knowledge of all types of aggregate safety reports.
  • 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 Microsoft Word, PowerPoint and Excel.

Scope:

Establishes strategic plans for designated function(s) and participates with others in management to align objectives across the organization.  Develops methods, techniques, and evaluation criteria for projects, programs, and people. Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives.  Erroneous decisions will have a serious impact on the overall success of functional area and may impact the long term success of the company.

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 by car or airplane independently up to 25% of the time and work after hours if required by travel schedule or business issues.

ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity

Apply for this Job

* Required

  
  


U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at ACADIA Pharmaceuticals are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Form CC-305

OMB Control Number 1250-0005

Expires 1/31/2020

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

Because we do business with the government, we must reach out to, hire, and provide equal opportunity to qualified people with disabilities1. To help us measure how well we are doing, we are asking you to tell us if you have a disability or if you ever had a disability. Completing this form is voluntary, but we hope that you will choose to fill it out. If you are applying for a job, any answer you give will be kept private and will not be used against you in any way.

If you already work for us, your answer will not be used against you in any way. Because a person may become disabled at any time, we are required to ask all of our employees to update their information every five years. You may voluntarily self-identify as having a disability on this form without fear of any punishment because you did not identify as having a disability earlier.

How do I know if I have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Blindness
  • Deafness
  • Cancer
  • Diabetes
  • Epilepsy
  • Autism
  • Cerebral palsy
  • HIV/AIDS
  • Schizophrenia
  • Muscular dystrophy
  • Bipolar disorder
  • Major depression
  • Multiple sclerosis (MS)
  • Missing limbs or partially missing limbs
  • Post-traumatic stress disorder (PTSD)
  • Obsessive compulsive disorder
  • Impairments requiring the use of a wheelchair
  • Intellectual disability (previously called mental retardation)
Reasonable Accommodation Notice

Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.