May 31st, 2022 Drug Safety

Senior Scientist Drug Safety Pharmacovigilance

Princeton, New Jersey, United States

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Please be aware that Acadia has a mandatory COVID-19 vaccination policy for all employees.

Position Summary:

The Safety Scientist will provide scientific support to the Drug Safety and PV (DSP) physicians. Appropriately perform core signal detection activities, elevate product issues impacting benefit-risk, priorities, resources, and achievements with appropriate oversight. Assist with the authoring of responses to health authority queries and other activities related to the findings of safety information for Acadia products at all stages of the product life cycle (development to post-marketing). Scientific and PV expertise will be employed to support evaluations of Acadia products throughout their lifecycles.

Primary Responsibilities:

  • Support the Acadia DSP physicians as appropriate for safety scientific activities from clinical trials and post-marketing experiences.
  • Resolve search strategy and author similar events (AOSE) with the alignment of PV physicians.
  • Support preparation of RMP and post-marketing safety monitoring activities.
  • Perform the analysis of potential safety signals according to SOPs and guidelines.
  • Ensure safety issues are communicated to the appropriate collaborators in a timely fashion.
  • In collaboration with PV physicians perform investigation and review of emerging safety data from various sources including published literature, aggregate reports, toxicology reports, non-clinical studies, and other sources.
  • Author and facilitate the preparation of safety reports required by health authorities such as Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), US Periodic Adverse Drug Experience Report (PADER), etc.
  • Help prepare drug-safety-related regulatory reports and clinical study documents (including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), MedDRA coding of AEs, product package, and labeling.
  • Participate in Safety Management Team meetings.
  • Other duties as assigned.

Education/Experience/Skills:

  • Clinical/graduate degree or equivalent (e.g. Pharm D, Ph.D., RN, BSN) required.
  • 7-10 years within the pharmaceutical/biotechnology industry with at least 5 years in a safety-related role and understanding of epidemiology preferred
  • Detailed understanding ideally based upon direct experience, of approaches to signal management, including quantitative signaling tools.
  • Experience in guiding the preparation and authoring of aggregate safety reports as well as benefit-risk statements.
  • Experience with validated drug safety databases (preferably ARGUS) and MedDRA.
  • Excellent oral and written communication skills and work well in cross-functional teams.
  • Attention to detail, excellent analytical skills, and ability to work independently.
  • Strong interpersonal, negotiating, and team-building skills.

Scope:

Conducts PV activities to achieve goals in accordance with established policies, meet schedules and overcome challenges. 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 the functional areas and related interpersonal objectives. Erroneous decisions will have a serious impact on the overall success of the functional areas and may impact the long-term progression 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.

#LI-Hybrid #LI-MH1

What we offer you:

  • 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:

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 [email protected] 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.