We are seeking a motivated individual to join our Drug Safety group within the Clinical Development function. The individual will work together with the Head of Drug Safety, Medical Monitor, and Study team members in managing study drug safety activities, including safety assessments of products throughout their lifecycle and oversight of global drug safety processes and other delegated safety activities. In addition, will also perform some operational activities to support the development of the department infrastructure to ensure compliance of pharmacovigilance activities with appropriate regulations and quality standards. This position reports to Senior Director, Drug Safety.
Conduct medical review of individual case safety reports (ICSR) within workflow timelines and per ICH-GCP guidelines, regulatory requirements and company’s SOPs.
Perform quality control review of all SAE cases to ensure medical accuracy, integrity and completeness of information reported and entered in the safety database.
Contribute to the review, development, and reporting of drug safety information to regulatory authorities, including but not limited to individual case safety reports (ICSRs), INDs, NDAs, annual report summary statements, and Periodic or Developmental Safety Update Reports.
Provide guidance and review of safety section(s) of study protocols, IC, forms, IB/DCSI updates, SPI, etc.
Interact with business stakeholders, CROs, etc., for assigned products and clinical programs. Participate in meetings for different clinical programs.
Perform routine surveillance review and evaluation of safety aggregate data as part of routine and ad-hoc signal detection activities and contribute to the development of risk management plans.
Contribute to the development, review, and update of new Drug Safety/Pharmacovigilance SOPs, drug safety processes, Safety Data Exchange Agreements. and other safety related tasks to support the development of the department infrastructure.
Participate in the organization and maintenance of safety information.
Other projects when assigned.
M.D. or Pharm.D. degree highly preferred, specialization and/or experience in oncology or hematology preferred.
Minimum of 12+ years of safety/pharmacovigilance hands on experience in clinical and post-marketing with global product responsibility
Excellent knowledge and understanding of FDA, EU and ICH guidelines and regulations governing clinical trials and post marketing safety
Great knowledge of principles of clinical assessment of adverse events in the pharmaceutical industry
Ability to evaluate and interpret medical clinical and scientific data
Excellent clinical judgement and ability to articulate complex clinical issues in a scientifically sounds and understandable way
Subject matter expert in performing medical review of all types of ICSRs from all report sources.
Experience in Safety systems (either Argus or AERS, ARISg) and understanding of aggregate data is required.
Hands-on experience with case evaluation, signal detection activities, including analyzing/categorizing/assessing data.
Understanding of Pharmacovigilance Operational activities.
Excellent interpersonal and written communication and ability to influence others
Demonstrate cross-functional collaboration, ability to work effectively in a team setting to resolve issues and reach solutions
Demonstrated ability to utilize effective critical thinking and problem-solving skills
Expertise in MedDRA dictionary relevant to AE/SAE coding
High attention to detail and accuracy
Strong commitment to business ethics