Associate Director, ICSR Management Team - Job ID: 1755CA
Scorpion Therapeutics, East Palo Alto, California, United States
Role Summary
The Associate Director, ICSR Management Team reports to the Director, Head, ICSR Management Team within the Global Patient Safety (GPS) organization. Under the direction of the Head, ICSR Management, is responsible for all assigned ICSR Management activities including ICSR processing workflow management, submission and follow-up activities. Responsibilities
Act as a Subject Matter Expert (SME) with regards to processing of Individual Case Safety Reports (ICSRs) and provide strategic input on case processing activities for Ascendis products. Ensure that all safety reports received from any source for Ascendis Products are processed in the safety database and are reported according to ICH-GCP guidelines, Health Authority regulations and company SOPs, Work Instructions and Business Partner agreements. Responsible for operational activities of ICSRs processed by PV Vendor and provide feedback and guidance as applicable. Assist in the oversight of the PV Vendor processing ICSRs for Ascendis Products. Perform Quality Checks of processed ICSRs and provide feedback to PV Vendor as applicable. Coordinate follow up activities for missing or ambiguous safety information as appropriate. Support vendor oversight by monitoring performance metrics/KPIs. Provide input to assigned vendors to improve the quality of Adverse Event intake. Perform late case investigation and risk mitigation strategy. Ability to review late case(s) to determine Root Cause Analysis (RCA) and create Corrective Action and Preventative Action (CAPA) as applicable. Oversee regulatory and departmental compliance by ensuring timely processing of ICSRs in the Safety Database and submission to Health Authorities or partners as applicable. Ensure any non-compliance or late ICSR are identified and ensure deviations are filed in accordance with Ascendis requirements. Ensure data integrity for safety data outputs from the Safety Database for aggregate reports, Health Authority requests or other safety requirements. Liaise with other functional groups for implementation of PV related processes requiring cross functional collaboration. Draft and update departmental SOPs, Work Instructions, etc. as applicable and ensure compliance with regulatory guidelines and regulations. Identify and develop training documents (i.e., SOPs) for the targeted audience (as needed). Train GxP vendors on processes corresponding to identification and reporting of Adverse Events to Ascendis Global Patient Safety. Train Internal and External employees on the use of Ascendis Safety Database as assigned. Function as a PV advisor to Ascendis Clinical Development Organizations, Medical Affairs, Commercial Organizations and PV staff as applicable. Identify opportunities for process improvements and participate in process optimization initiatives. Support Medical Safety Science team with activities related to signal detection, risk management and health authority responses as needed. Raise or increase awareness, knowledge and understanding of pharmacovigilance requirements by conducting education/training sessions with functional partners / vendors as required. Support Case Transmission Verification (CTV) and SAE Reconciliation activities as needed. Collaborate with PV Information Technology team on implementation and maintenance of the Global Safety Database and Safety Reporting rules within the Safety Database. Review and provide input to Business Partner or Pharmacovigilance Agreements and Safety Data Exchange Agreements (SDEA) to ensure appropriate safety exchange requirements are established and adhered to. Contribute to the maintenance of Ascendis Pharmacovigilance System Master File (PSMF). Represent during PV related regulatory inspections or internal quality assurance/corporate compliance audits in coordination with GCP and PV Compliance teams. Work collaboratively with Vendor Management, Study Management, QPPV Office and Medical Safety Science teams for assigned activities. Responsible for any assigned US applicable Risk Management Plan Implementation Coordination activities and associated tracking as necessary. Maintain oversight of activities within the scope of Ascendis PV group under the direction of Head, ICSR management (e.g., Local PV agreements, CRMs, Digital Media). Participate in relevant crisis management activities within the scope of Ascendis PV group. Qualifications
Bachelor’s degree in a health care field with relevant pharmaceutical industry experience in drug safety. Candidates with advanced scientific degrees and extensive drug safety experience is highly desired. Minimum of 8 years recent experience in Pharmacovigilance. Working knowledge of validated Drug Safety Databases (Argus preferred). Experience with MedDRA coding and global safety reporting regulatory requirements. Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations. Ability to travel up to 20% of the time domestically and internationally. Skills
Competencies Identified For Success: Works effectively, independently, and collaboratively; strong organizational skills, detail oriented and adaptable in a dynamic, fast-paced environment; demonstrates ownership, initiative, and accountability; effective team player; excellent written and verbal communication; strong analytical and decision-making abilities; high level of commitment.
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The Associate Director, ICSR Management Team reports to the Director, Head, ICSR Management Team within the Global Patient Safety (GPS) organization. Under the direction of the Head, ICSR Management, is responsible for all assigned ICSR Management activities including ICSR processing workflow management, submission and follow-up activities. Responsibilities
Act as a Subject Matter Expert (SME) with regards to processing of Individual Case Safety Reports (ICSRs) and provide strategic input on case processing activities for Ascendis products. Ensure that all safety reports received from any source for Ascendis Products are processed in the safety database and are reported according to ICH-GCP guidelines, Health Authority regulations and company SOPs, Work Instructions and Business Partner agreements. Responsible for operational activities of ICSRs processed by PV Vendor and provide feedback and guidance as applicable. Assist in the oversight of the PV Vendor processing ICSRs for Ascendis Products. Perform Quality Checks of processed ICSRs and provide feedback to PV Vendor as applicable. Coordinate follow up activities for missing or ambiguous safety information as appropriate. Support vendor oversight by monitoring performance metrics/KPIs. Provide input to assigned vendors to improve the quality of Adverse Event intake. Perform late case investigation and risk mitigation strategy. Ability to review late case(s) to determine Root Cause Analysis (RCA) and create Corrective Action and Preventative Action (CAPA) as applicable. Oversee regulatory and departmental compliance by ensuring timely processing of ICSRs in the Safety Database and submission to Health Authorities or partners as applicable. Ensure any non-compliance or late ICSR are identified and ensure deviations are filed in accordance with Ascendis requirements. Ensure data integrity for safety data outputs from the Safety Database for aggregate reports, Health Authority requests or other safety requirements. Liaise with other functional groups for implementation of PV related processes requiring cross functional collaboration. Draft and update departmental SOPs, Work Instructions, etc. as applicable and ensure compliance with regulatory guidelines and regulations. Identify and develop training documents (i.e., SOPs) for the targeted audience (as needed). Train GxP vendors on processes corresponding to identification and reporting of Adverse Events to Ascendis Global Patient Safety. Train Internal and External employees on the use of Ascendis Safety Database as assigned. Function as a PV advisor to Ascendis Clinical Development Organizations, Medical Affairs, Commercial Organizations and PV staff as applicable. Identify opportunities for process improvements and participate in process optimization initiatives. Support Medical Safety Science team with activities related to signal detection, risk management and health authority responses as needed. Raise or increase awareness, knowledge and understanding of pharmacovigilance requirements by conducting education/training sessions with functional partners / vendors as required. Support Case Transmission Verification (CTV) and SAE Reconciliation activities as needed. Collaborate with PV Information Technology team on implementation and maintenance of the Global Safety Database and Safety Reporting rules within the Safety Database. Review and provide input to Business Partner or Pharmacovigilance Agreements and Safety Data Exchange Agreements (SDEA) to ensure appropriate safety exchange requirements are established and adhered to. Contribute to the maintenance of Ascendis Pharmacovigilance System Master File (PSMF). Represent during PV related regulatory inspections or internal quality assurance/corporate compliance audits in coordination with GCP and PV Compliance teams. Work collaboratively with Vendor Management, Study Management, QPPV Office and Medical Safety Science teams for assigned activities. Responsible for any assigned US applicable Risk Management Plan Implementation Coordination activities and associated tracking as necessary. Maintain oversight of activities within the scope of Ascendis PV group under the direction of Head, ICSR management (e.g., Local PV agreements, CRMs, Digital Media). Participate in relevant crisis management activities within the scope of Ascendis PV group. Qualifications
Bachelor’s degree in a health care field with relevant pharmaceutical industry experience in drug safety. Candidates with advanced scientific degrees and extensive drug safety experience is highly desired. Minimum of 8 years recent experience in Pharmacovigilance. Working knowledge of validated Drug Safety Databases (Argus preferred). Experience with MedDRA coding and global safety reporting regulatory requirements. Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations. Ability to travel up to 20% of the time domestically and internationally. Skills
Competencies Identified For Success: Works effectively, independently, and collaboratively; strong organizational skills, detail oriented and adaptable in a dynamic, fast-paced environment; demonstrates ownership, initiative, and accountability; effective team player; excellent written and verbal communication; strong analytical and decision-making abilities; high level of commitment.
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