Medical Director, Drug Safety

Overview

Provides medical expertise within the Drug Safety department throughout the lifecycle of products in development and post marketing. Contributes to the analysis, review, and approval of Individual Case Safety Reports (ICSRs) and contributes to and provides the medical review for aggregate safety reports, including but not limited to analyses of adverse events, Periodic Reports (eg, DSURs, PSUR/PBRERs, PADERs) for marketed and investigational products. Supports the ongoing evaluation of safety information for products in development and on the market for signal detection purposes and to provide proactive risk management strategies.

Essential Functions and Responsibilities

• Reviews all appropriate safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the product development life cycle to proactively identify any new safety issues that may require further evaluation to determine a causal relationship with products in development or on the market.
• Conducts medical review and assessment of clinical trial and post marketing cases for all products, ensuring the case narratives are medically accurate, the events within cases are properly coded and have the proper labeling assessment, and that cases are queried for additional information as needed.
• Authors the analysis of similar events (AOSE) for any expedited cases.
• Authors or provides medical review of all aggregate safety reports such as Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports (PSURs/PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Investigational New Drug (IND) Annual reports, and line listings of Suspected Unexpected Serious Adverse Reactions (SUSARs) for regulatory submission.
• Authors or contributes to safety sections of regulatory submissions, including New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and responses to regulatory authorities.
• Provides product safety training to internal employees and external contractors / vendors as needed.
• Participates in investigators’ meetings to provide training on adverse events reporting as required.
• May prepare and present product safety issues at internal and external meetings.
• Assists in the creation, review and implementation of new Standard Operating Procedures (SOPs), Work Instructions, guidelines, documents and other tools pertaining to the role.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

• A doctoral-level degree in medicine or equivalent combination of education and experience. Clinical experience in the practice of medicine.
• Knowledge of pre- and post-marketing US and Global regulations for pharmacovigilance, including the Code of Federal Regulations, the European Union Good Pharmacovigilance Practices modules, and the International Council for Harmonization (ICH) guidelines and principles.
• Familiar with Medical Coding (eg, MedDRA, WHO-Drug).
• Proficient with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and safety databases (eg, ARISg, ARGUS, etc.).
• Excellent verbal and written communication skills (proficient in English).
• Ability to multitask under tight deadlines while providing attention to detail and high-quality work in a fast-paced and dynamic environment.
• Ability to be flexible, adapt to change, and work independently or as part of a multi-disciplinary team
• Experience working in a matrix environment.
• Ability to be customer-focused and have a disciplined approach to work.

Preferred Education, Skills, and Knowledge

• At least 5 years of experience in pharmacovigilance organizations is preferred.

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