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Director, Safety Science

2 weeks, 2 days ago
Anywhere
Full-time
Senior
Data Scientist
Data Science and Analytics
Power BI R Statistics
Apply Now
Celcuity

Celcuity

Celcuity is a clinical stage biotechnology company that unravels complexity and harnesses insights to develop targeted therapies for cancer patients. Their platform provides unparalleled insights into oncogenic pathways, with their lead candidate being...

Biotechnology
11-50
Founded 2012
$214M raised
View All Jobs 15

Description

  • Support Safety Physicians with safety-related tasks across commercial products and products in clinical development.
  • Build knowledge of the relevant drug class and competitor safety issues.
  • Contribute to safety risk management through routine review of safety data and relevant scientific literature.
  • Conduct signal detection activities and safety data analyses to support benefit-risk assessments and governance decisions.
  • Prepare and update safety documents and deliverables, including DSURs, PADERs/PBRERs, RMPs, SDEAs, protocols, IB safety content, ICFs, briefing books, NDA materials, CSRs, and CCDS.
  • Assist with regulatory dossier submissions, including Clinical Overviews, Clinical Evaluation Reports, and Summaries of Clinical Safety.
  • Represent Clinical Safety in study team meetings and coordinate with internal and external stakeholders to meet safety milestones.
  • Develop and review departmental quality documents, such as SOPs and working guidelines.
  • Respond to safety queries from regulatory agencies and other third parties.
  • Prepare and present safety data summaries to internal and external stakeholders, including Data Monitoring Committees.
  • Conduct literature searches and develop search strings for safety-related review activities.
  • Support quality systems, inspection readiness, audits, and inspections.

Requirements

  • Relevant postgraduate qualification such as an MSc or equivalent in healthcare or a life sciences discipline; a PhD or other postgraduate health professional qualification is a plus.
  • 5+ years of drug development experience in the pharmaceutical or related industry.
  • At least 3 years of experience in drug safety/pharmacovigilance.
  • At least 2 years of data management and analysis experience.
  • Experience with large or post-market databases such as FAERS or EudraVigilance is preferred.
  • Familiarity with safety databases and the ability to extract, handle, or mine data from databases as needed.
  • Hands-on experience with analytical tools such as Excel, R, Power BI, or similar tools, plus knowledge of safety analytics and relevant statistics.
  • Knowledge of pharmacovigilance and the signal detection/evaluation process.
  • Strong presentation skills and the ability to summarize and present data effectively to diverse stakeholders.
  • Experience in oncology through clinical practice, drug development, or related industry work is a plus.
  • In-depth understanding of global clinical safety and pharmacovigilance regulations and guidelines, including GVP, FDA, and EMA requirements.
  • Proficiency with pharmacovigilance databases and tools such as Argus and MedDRA coding.
  • Proven track record preparing and reviewing regulatory safety documents, including DSURs and risk management plans.
  • Excellent written and verbal communication skills.
  • Attention to detail, strong organizational skills, and the ability to manage multiple processes and priorities.
  • Advanced knowledge of MS Office, including Word, Excel, and PowerPoint.
  • Ability to work independently or as part of a team.

Benefits

  • Base salary range of $190,000 to $220,000 DOE.
  • Annual performance incentive bonus.
  • New hire equity package.
  • Medical, dental, and vision insurance.
  • 401(k) match.
  • PTO.
  • Paid holidays.

Interested in this position?

Apply directly on the company website

Apply Now

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