Full-Time

Executive Director Drug Safety and Pharmacovigilance

Confirmed live in the last 24 hours

Acadia Pharmaceuticals

Acadia Pharmaceuticals

501-1,000 employees

Develops therapies for neurological disorders

Biotechnology
Healthcare

Senior, Expert

Princeton, NJ, USA

Hybrid model requires in-office presence three days per week on average.

Category
Physicians & Surgeons
Medical, Clinical & Veterinary
Required Skills
Word/Pages/Docs
Google Cloud Platform
Excel/Numbers/Sheets
Requirements
  • MD degree or equivalent with clinical post-training resulting in eligibility for a US medical board certification.
  • Senior Director level: Targeting 10+ years of relevant drug safety experience in the biotechnology/pharmaceutical industry, including safety leadership experience.
  • Executive Director level: Targeting 15+ years of relevant drug safety experience in the biotechnology/pharmaceutical industry, including safety leadership experience.
  • 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.
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.
Desired Qualifications
  • MPH or pharmacoepidemiology expertise desired.
  • Neurology, psychiatry, or CNS-related disease experience preferred.
Acadia Pharmaceuticals

Acadia Pharmaceuticals

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Acadia Pharmaceuticals develops therapies for neurological disorders, focusing on conditions like Parkinson's disease, schizophrenia, and Rett syndrome. The company conducts extensive research and clinical trials to create drugs that are safe and effective, seeking approval from regulatory bodies like the FDA before bringing them to market. Acadia stands out from competitors by concentrating on areas with significant unmet medical needs and forming strategic partnerships to enhance its research and market presence. The goal of Acadia Pharmaceuticals is to improve the quality of life for patients suffering from challenging neurological diseases through effective treatments.

Company Stage

Acquired

Total Funding

$813.4M

Headquarters

Dallas, Texas

Founded

1993

Simplify Jobs

Simplify's Take

What believers are saying

  • Acadia's recent Health Canada approval for Daybue boosts its market presence in Canada.
  • The exclusive license agreement with Saniona expands Acadia's drug portfolio with SAN711.
  • Hiring Thomas Andrew Garner as CCO strengthens Acadia's commercial leadership team.

What critics are saying

  • Increased competition in CNS drugs may impact Acadia's market share and growth.
  • Regulatory challenges could delay or prevent new drug approvals, affecting revenue.
  • High drug development costs may strain financial resources if trials are unsuccessful.

What makes Acadia Pharmaceuticals unique

  • Acadia focuses on unmet needs in neurological disorders like Parkinson's and Rett syndrome.
  • The company has a strong R&D pipeline with four product candidates in development.
  • Acadia collaborates with partners like Biovail to enhance drug development and commercialization.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Paid Vacation

Paid Holidays

Paid Sick Leave

Paid Parental Leave

Tuition Reimbursement