Associate Director, Risk Management - United States
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
• Develop strategies and perform signal detection activities for marketed and investigational products including signal identification, evaluation, interpretation of safety signals and trends, and communication of safety risks.
• Compile and assess data to support the effectiveness of risk minimization strategies, e.g. abstracting and interpreting data from safety and clinical databases, literature, data tabulations, laboratory values, etc. Provide the data to Medical Directors for approval.
• Collaborate with Medical Directors and other applicable functional area specialists including Biostatistics, Medical Affairs, Quality, Regulatory Affairs to identify, evaluate and manage safety signals for marketed and investigational products.
• Responsible for the development and maintenance of risk management documents such as, Risk Management Plans (RMPs) and Risk Evaluation & Mitigation Strategy (REMS).
• Responsible for the production and preparation of pre- and post- marketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/ Periodic Benefit-Risk Evaluation Report (PBERER), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND annual reports, etc.
• Contribute to and draft health authority and other safety related query responses.
• Collaborate with PV Operations in generating the processes to support risk management and signal detection activities.
• Perform or contribute to, and draft, Analysis of Similar Events.
• Collaborate with the team in pharmacovigilance audits and inspections. Remediate any pharmacovigilance deficiencies found during regulatory or internal audits, as needed.
• Oversees, performs, and tracks activities related to updating risk information communicated in documents such as, labeling, Investigational Brochure, informed consent forms, Investigator Letters, etc.
• Managing and supporting external/independent safety review committees such as data safety monitoring committees and adjudication committees.
• Oversees and performs periodic data reviews (Table/Listing/Figure reviews, AE and con-med coding reviews) and data mining activities
• Coordinate and lead activities related to Regulatory Inspections, draft audit responses and track regulatory and stakeholder commitments related to safety surveillance and risk management
• Generate and oversee the execution of departmental WIs, SOPs and training related to pre- and post-marketing risk management
• Collaborate with affiliates, QPPV, QA, Training, Product Complaints, Contact Center and stakeholders
• Supervise and manage vendors as applicable to risk management commitments
• Review and contribute to protocols, Investigator’s brochure and other study related material for pre- and post-marketing clinical trials
• -Pharm D, Pharmacist, RN, MD or other relevant training and education in the biomedical field with over 8 years of experience in the pharmaceutical industry and a minimum of 3 years in leadership positions in pharmacovigilance.
• -Solid understanding of the cross functional drug development processes (Clinical operations, Data Management, Biostats, and Regulatory).
• -Proficiency with standard desktop computing programs (e-mail, Word, Excel) and relational databases.
• -Excellent verbal and written communication skills, detail-oriented personality, and ability to work across functions.
• -Experience in managing CRO/vendors.
• -Must be self-motivated, highly organized, detail-oriented and able to multi-task with delivering high quality work.
• -Must be able to manage their own work, with ability to prioritize, plan and organize work assignments of the team while working under strict timelines.
• -Must be able to develop business solutions to complex problem.