Director, Safety Science
Celcuity
4 hours ago
Remote friendly (United States)
United States
$190,000 - $220,000 USD yearly
Medical Affairs
Responsibilities:
- Support Safety Physicians with safety-related tasks across commercial products and products in clinical development.
- Contribute to safety risk management, including routine review of safety data and relevant scientific literature.
- Conduct signal detection activities and analyses of safety data to support benefit-risk assessment; present findings in safety review/governance meetings and support implementation of signal evaluation decisions (updates to safety documents and risk mitigation measures).
- Contribute to preparation of safety documents (e.g., DSURs, PADERs/PBRER, RMPs, SDEAs, safety sections of protocols, reference safety information, NDA/CSRs/CCDS).
- Assist with regulatory dossier submissions (e.g., Clinical Overviews, Clinical Evaluation Reports, Summaries of Clinical Safety).
- Represent Clinical Safety in study team meetings; collaborate with internal/external stakeholders to deliver safety milestones.
- Develop and review departmental quality documents (e.g., SOPs and working guidelines).
- Respond to safety queries from third parties (e.g., regulatory agencies).
- Prepare and present safety data summaries to internal/external stakeholders (e.g., Data Monitoring Committees).
- Conduct literature searches and develop search criteria strings.
- Support quality systems, inspection readiness, audits, and inspections.
- Other duties as assigned.
Qualifications:
- Relevant postgraduate qualification (e.g., MSc or equivalent; PhD or other post-graduate health professional qualification a plus).
- 5+ years drug development experience in pharma/related industry, including 3+ years in drug safety/pharmacovigilance.
- 2+ years data management and analysis experience; experience with large databases/post-market systems (FAERS, EudraVigilance) preferred.
- Familiar with safety databases; able to extract/handle data (data mining) as needed.
- Hands-on analytical tools (Excel; R, Power BI, or other analytics) and knowledge of safety analytics/statistics.
- Knowledge of pharmacovigilance and signal detection/evaluation process.
- Strong presentation, written/verbal communication, technical/analytical, and organizational skills.
- Proficiency with pharmacovigilance tools/databases (e.g., Argus; MedDRA coding).
- Proven track record preparing/reviewing regulatory safety documents (e.g., DSURs, risk management plans).
- In-depth knowledge of global clinical safety/pharmacovigilance regulations (GVP, FDA, EMA).
- Oncology therapeutic area experience is a plus.
- Advanced MS Office skills (Word/Excel/PowerPoint); ability to work independently or as part of a team.
- Support Safety Physicians with safety-related tasks across commercial products and products in clinical development.
- Contribute to safety risk management, including routine review of safety data and relevant scientific literature.
- Conduct signal detection activities and analyses of safety data to support benefit-risk assessment; present findings in safety review/governance meetings and support implementation of signal evaluation decisions (updates to safety documents and risk mitigation measures).
- Contribute to preparation of safety documents (e.g., DSURs, PADERs/PBRER, RMPs, SDEAs, safety sections of protocols, reference safety information, NDA/CSRs/CCDS).
- Assist with regulatory dossier submissions (e.g., Clinical Overviews, Clinical Evaluation Reports, Summaries of Clinical Safety).
- Represent Clinical Safety in study team meetings; collaborate with internal/external stakeholders to deliver safety milestones.
- Develop and review departmental quality documents (e.g., SOPs and working guidelines).
- Respond to safety queries from third parties (e.g., regulatory agencies).
- Prepare and present safety data summaries to internal/external stakeholders (e.g., Data Monitoring Committees).
- Conduct literature searches and develop search criteria strings.
- Support quality systems, inspection readiness, audits, and inspections.
- Other duties as assigned.
Qualifications:
- Relevant postgraduate qualification (e.g., MSc or equivalent; PhD or other post-graduate health professional qualification a plus).
- 5+ years drug development experience in pharma/related industry, including 3+ years in drug safety/pharmacovigilance.
- 2+ years data management and analysis experience; experience with large databases/post-market systems (FAERS, EudraVigilance) preferred.
- Familiar with safety databases; able to extract/handle data (data mining) as needed.
- Hands-on analytical tools (Excel; R, Power BI, or other analytics) and knowledge of safety analytics/statistics.
- Knowledge of pharmacovigilance and signal detection/evaluation process.
- Strong presentation, written/verbal communication, technical/analytical, and organizational skills.
- Proficiency with pharmacovigilance tools/databases (e.g., Argus; MedDRA coding).
- Proven track record preparing/reviewing regulatory safety documents (e.g., DSURs, risk management plans).
- In-depth knowledge of global clinical safety/pharmacovigilance regulations (GVP, FDA, EMA).
- Oncology therapeutic area experience is a plus.
- Advanced MS Office skills (Word/Excel/PowerPoint); ability to work independently or as part of a team.