Associate Director, Patient Safety & Pharmacovigilance Science

Responsibilities:

Safety Data Analysis & Signal Detection:

• Perform safety data analyses using appropriate data sources, including case series reviews, data summaries and AE trend information
• Collaborate with safety physicians on signal detection and risk management activities. Perform safety data monitoring, analysis, and interpretation
• Review of medical and scientific literature for signal detection and aggregate reporting activities

Safety Documentation & Reporting:

• Develop and maintain components of Risk Management Plans (RMPs)/Risk Evaluation and Mitigation Strategies (REMS), and other risk management documents for assigned product(s)
• Prepare and review aggregate safety reports for assigned product(s)
• Provide safety input to statistical analysis plans, data analysis visualizations, and documents requiring safety analysis to ensure consistent presentation of safety and risk management topics for assigned product(s)
• Author and review safety reports and regulatory deliverables, including Integrated Summaries of Safety (ISS) and other submission-related documents

Cross-Functional Collaboration:

• Participate in safety governance meetings and support safety deliverables related to cross functional or benefit-risk assessment meetings, including creation and maintenance of product core safety information and company core data sheets (CCDSs)
• Contribute to and review safety sections of clinical documents, including Investigator’s brochure (IB), clinical study protocols, and clinical study reports

Regulatory & External Engagement:

• Work closely with safety physicians and cross-functional stakeholders in authoring the safety safety content for regulatory submissions and other key regulatory deliverables (e.g., NDA, Briefing Document)
• Prepare and review responses to health authority or other safety related query responses for assigned product(s)

Leadership & Team Development:

• Mentor, train and collaborate with junior scientists on signal detection and risk management activities
• Support PV vendor oversight and continuous process improvement

Preferred Skills, Qualifications and Technical Proficiencies:

• Ability to work in a dynamic environment to meet corporate and patient needs
• Excellent working knowledge of Argus (or similar applications), MS Office applications, electronic data capture systems, and MedDRA and WHO Drug coding dictionaries
• Excellent presentation, communication, and collaboration skills
• Knowledge of global PV regulations and guidelines (e.g., ICH, GVP, FDA, EMA)

Preferred Education and Experience:

• PhD, PharmD or other advanced degree in related discipline is preferred. Other relevant experience may be considered without an advanced degree; BS/BA degree in related discipline is required. Training or equivalent experience in epidemiology or public health is beneficial but not required
• 4+ years in experience in patient safety and pharmacovigilance in the capacity of a scientist, including experience in safety surveillance, signal detection and evaluation, aggregate reporting, and risk management activities. At least 2 years of clinical development experience is required
• Experience in writing safety analyses, performing signal detection or safety surveillance, risk management and preparing responses to HA
• Authoring and review of periodic and ad hoc safety reports and clinical development documents, including PSURs/PBRERs, DSURs, Clinical Overviews, Clinical Study Reports, Investigator's Brochures, or related documents
• Experience with industry standard pharmacovigilance data systems (e.g., Oracle Argus, data analytics, and signal management tools)
• Experience with NDA/MAA filing is beneficial but not required