Responsible for oversight and management of Individual Case Safety Report (ICSR) processing for marketed and investigational products across all case types including spontaneous, clinical trial and litigation. Responsible for oversight of case processing vendor including training and mentoring of vendor case processing staff. Guide vendor on resource scheduling and workflow to ensure that case processing activities from receipt through submission are carried out in accordance with relevant regulatory requirements and established company processes. Perform Quality Control (QC) activities related to case processing. Serve as subject matter expert (SME) related to case processing and assist in the development of safety surveillance processes and writing corresponding SOPs.
Responsible to ensure timely, consistent and accurate case processing and safety reporting in accordance with ICH guidelines, applicable regulatory requirements, Good Clinical Practices (GCPs) and standard operating procedures (SOPs).
Key Accountabilities
Accountability Responsibilities % of Time
Individual Case Safety Report (ICSR) Processing
Oversee end-to-end ICSR processing for all products (i.e., marketed, investigational, branded and generic) and all case types including spontaneous, clinical trial and litigation.
Monitor workload and workflows to ensure on time submissions to regulatory authorities and partners
Guide vendor staff on day-to-day ICSR processing activities including mailbox management registration, triage, entry, QC, medical review, submission and follow-up activities are carried out in accordance with relevant regulatory requirements and established company processes
Triage and resolve case processing issues and escalate to management, as needed
Perform quality review of ICSRs and provide feedback to vendor, as needed.
40%
Oversight, Mentoring & Training of Vendor Staff
Oversee end-to-end ICSR processing for all products
Serve as primary point of contact for vendor on all aspects related to ICSR processing
Train and mentor vendor staff in processing of ICSRs
40%
Process Improvement
Participate on cross functional, multidisciplinary teams and contribute to defining case processing guidelines
Partner with Case Processing, Quality/Compliance and Safety Systems management to ensure efficient and compliance case processing.
Assist in the development of safety surveillance processes and writing corresponding SOPs
Co-author / co-develop data entry process instructions and update accordingly when processes and procedures change
Perform quality review of ICSRs to identify and resolve process issues
Develops follow-up processes (letters, questionnaires and phone contact) to obtain relevant medical information pertinent to case analysis and signal detection
20%
Qualifications
Education & Experience
Bachelor's Degree in life sciences, pharmacy, nursing (RN, PharmD) or combination of Health Related Degree and clinical experience in a medical setting. Advanced Degree preferred.
Eight (8) years of experience in pharmaceutical drug safety/pharmacovigilance case processing including branded and generic products and all case types (spontaneous, clinical trial and litigation).
Experience in triaging of cases, coding of terms using MedDRA, data entry and narrative writing.
Vendor oversight experience highly desired.
Knowledge
Extensive working knowledge of FDA regulations, FDA guidance and ICH guidance; some familiarity exposure to EMEA regulations
High level of computer literacy, particularly in the use and management of Drug Safety databases including ICSR data entry, regulatory reporting, and data querying
In-depth understanding of the ICSR assessment and reporting process
Skills & Abilities
Highly organized, analytical, and logical in approach to all assigned tasks
Strong leadership & project management skills. Ability to manage multiple priorities and manage resources to drive completion.
Excellent interpersonal, oral and written communication skills
Ability to provide coaching, guidance, and feedback to help others excel on the job and meet key accountabilities
Skilled in Microsoft Office applications (Word, PowerPoint, Excel)