Full-Time

Director Risk Management

Drug Safety

Posted on 5/3/2024

Acadia Pharmaceuticals Inc.

Acadia Pharmaceuticals Inc.

501-1,000 employees

Develops therapies for neurological disorders

Biotechnology

Senior

Princeton, NJ, USA

Required Skills
Communications
Management
Marketing
Requirements
  • Master’s Degree in Public Health or related field required
  • 10 years of progressive applied epidemiology experience in a regulated biotechnology or pharmaceutical industry required
  • PhD with 4 years of progressive applied epidemiology experience
  • Experience in regulatory requirements and guidelines pertaining to Drug Safety and Pharmacovigilance
  • Proficiency in performing data mining activities for analysis of safety data
  • Experience with publishing original research in peer-reviewed journals and formal presentations at scientific meetings
  • Proficiency with standard desktop and pharmacovigilance computing programs such as Argus and Arisg
  • Proficiency with Empirica/Topics, Spotfire or other signal management tools
  • Excellent written and oral communications
  • Ability to prioritize and organize work to meet deadlines
  • Excellent project and time management as well as strategic planning skills
  • Ability to work independently as well as in a team environment
  • Ability to apply relevant FDA, EU and ICH guidelines
Responsibilities
  • Leads the development and management of a comprehensive risk management system for risk detection, risk assessment and risk minimization for all products
  • Integral member of safety signaling committee and potentially other internal multi-disciplinary teams as assigned
  • Support any applicable regulatory submissions including Marketing Authorization Applications (MAA), New Drug Applications (NDA) and Biologic License Applications (BLA)
  • Manages safety related committees, including the Signaling Committee, Executive Safety Committee, and SERM team
  • Directs and collaborates on the development of product specific Risk Evaluation and Mitigation Strategy (REMS) in the event needed
  • Manages process related to the REMS delivery team and general oversight of REMS programs for Acadia products where a REMS would be required
  • Oversight and collaboration with stakeholders for preparation of Periodic Benefit Risk Evaluation Reports (PBRERs) for marketed products
  • Directs and collaborates on the development of Risk Management Plans (RMPs/dRMPs), as required for Acadia’s marketed and investigational products
  • Assure successful completion of any future RMP commitments including post-authorization safety studies (PASS) and measuring the effectiveness of any risk minimization strategies
  • Directs and collaborates on the production of Safety Discussion Documents (SDDs) in collaboration with Safety Physicians to assess and track safety signals
  • Functions as a subject matter expert internal to DSP for epidemiology and provides in-house epidemiology expertise to other departments upon request
  • Partners with Clinical Development and Medical Affairs teams in clinical trial planning regarding creation and conduct of risk management strategies utilizing pharmacoepidemiology research techniques (as applicable)
  • Provides estimates of incidence and prevalence of health conditions, disease progression and disease-specific risk factors
  • Responsible for analysis of safety data requests from Health Authorities in collaboration with safety physicians; Authors epidemiology relevant information for submission to health authorities as required, and provide support for manuscripts for publication
  • Provides epidemiologic consultation on the identification and assessment of safety risks, safety data interpretation as well as observational study and registry design, as needed
  • Consults with safety systems programmers in the development of standard adverse event and tables generated for signal detection
  • Draft SOPs and work instructions related to risk management, epidemiology and signal detection
  • Collaborate with Clinical Development, Medical Affairs and others to design, implement, and publish study results

Acadia Pharmaceuticals Inc.

Acadia Pharmaceuticals Inc.

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Acadia Pharmaceuticals Inc. stands out as a leader in the niche field of neurological and mental health therapy development, particularly focusing on conditions like schizophrenia, Parkinson's disease psychosis, and Rett syndrome. This specialization not only brings significant advancement in targeted therapies but also enhances the quality of life for individuals enduring these challenging conditions. Working at this company offers the chance to be part of a dedicated team that positively impacts patient lives through groundbreaking work in a highly specialized area of medicine.

Company Stage

IPO

Total Funding

$813.4M

Headquarters

San Diego, California

Founded

1993

Growth & Insights
Headcount

6 month growth

7%

1 year growth

14%

2 year growth

20%
INACTIVE