Director, Risk Management

Overview

The Director of Risk Management, Drug Safety, will report to the Head of Drug Safety and be responsible for overseeing the risk management activities for our products, ensuring compliance with global regulatory requirements, and providing strategic guidance to the Drug Safety team and other key stakeholders. The successful candidate will enhance or develop signal detection, signal management, aggregate report writing, and risk management planning processes to ensure the safety and efficacy of our pharmaceutical products as our company transitions from the development stage to commercial.

Essential Functions and Responsibilities

• Lead and execute signal detection activities, including the analysis of safety data from multiple sources (eg, clinical trials, post-marketing surveillance, published scientific literature, etc.), identification of potential safety signals, and evaluation of their clinical significance and impact to the risk-benefit profile of our pharmaceutical products.
• Develop and implement signal management procedures, including signal validation, signal assessment, signal prioritization, signal tracking, collaboration with relevant cross-functional teams, and establishment of risk minimization measurements, where necessary.
• Develop, implement, and maintain the risk management plans for all products, ensuring compliance with global regulatory requirements, company policies and procedures, and industry standards.
• Prepare and review aggregate safety reports, such as the Periodic Safety Update Report/Periodic Benefit-Risk Evaluation Report (PSUR/PBRER), Periodic Adverse Drug Experience Report (PADER), and Development Safety Update Report (DSUR) in compliance with international regulations and guidelines.
• Author safety portions of clinical documents, including Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), and others as required.
• Author regulatory response documents related to safety, including safety-related questions from regulatory agencies and safety-related components of regulatory submissions.
• Develop and deliver safety training to internal stakeholders, including training on safety data collection and reporting procedures, Good Pharmacovigilance Practices (GVP), and signal detection, evaluation, and management.
• Conduct in-depth safety data analysis, trend analysis, and data mining to identify emerging safety concerns, evaluate the risk-benefit profile of our pharmaceutical products, and provide guidance to cross-functional teams on mitigation strategies.
• Collaborate with cross-functional teams, including Medical Affairs, Clinical Research, Regulatory Affairs, Biometrics, and Quality Assurance, to provide expert input on safety-related matters throughout the product lifecycle.
• Stay current with new regulatory requirements, guidance documents, and industry trends related to risk management, aggregate reporting, and signal detection.
• Participate in pharmacovigilance inspections and audits and ensure timely implementation of corrective and preventive actions.
• Provide training and mentorship to junior pharmacovigilance team members, fostering their professional development and knowledge enhancement.
• Contribute to the improvement of pharmacovigilance systems, processes, standard operating procedures (SOPs), and Work Instructions (WIs) to optimize efficiency and quality of risk management.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

• Bachelor’s degree or advanced degree in life sciences or related field.
• 10  years of experience in pharmacovigilance, with a focus on signal detection, signal management, aggregate report writing, and risk management planning.
• Extensive knowledge of pharmacovigilance regulations and guidelines, including FDA regulations, EMA regulations, GVP guidelines, and ICH guidelines.
• Strong background in conducting signal detection activities, utilizing pharmacovigilance databases and applying statistical methods for signal identification.
• Proven expertise in authoring regulatory response documents related to safety, safety portions of clinical documents, and aggregate safety reports, such as PSURs/PBRERs, PADERs, and DSURs, in compliance with regulatory standards.
• Familiarity with risk management planning and implementation, including risk communication and the development of Risk Evaluation and Mitigation Strategies (REMS) and European Union Risk Management Plans (EU RMPs).
• Excellent analytical and problem-solving skills, with the ability to interpret complex safety data and identify trends and potential risks.
• Strong understanding of the drug development process, clinical trial regulations, and post-marketing safety surveillance.
• Effective communication and interpersonal skills, with the ability to collaborate with cross‑functional teams and communicate complex safety information to technical and non‑technical stakeholders.
• Demonstrated leadership abilities, including experience in leading projects, managing teams, and providing mentorship to colleagues.
• Proficiency in pharmacovigilance databases and signal detection tools.
• Knowledge of statistical techniques for signal detection and trend analysis is desirable.
• Strong attention to detail, organizational skills, writing skills, oral communication skills, and ability to manage multiple priorities effectively.
• Excellent computer skills in Microsoft environment (Excel, PowerPoint, and Word).

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards. 

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.

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