Ascendis Pharma A/S
Associate Director, ICSR Management Team - Job ID: 1755NJ
Ascendis Pharma A/S, Princeton, New Jersey, us, 08543
Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.
Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.
Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.
Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.
Overview
The Associate Director, ICSR Management Team reports to the Director, Head, ICSR Management within the Global Patient Safety (GPS) organization. Under the direction of the Head, ICSR Management, this role 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. Oversee operational activities of ICSRs processed by PV Vendor and provide feedback and guidance as applicable. Assist in the oversight of 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 and provide input to assigned vendors to improve Adverse Event intake quality. Perform late case investigation and risk mitigation; review late cases to determine Root Cause Analysis (RCA) and create 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. Identify and address non-compliance or late ICSRs 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. Collaborate with other functional groups for cross-functional PV process implementation and updates to SOPs/Work Instructions as applicable. Identify and develop training documents for targeted audiences and train GxP vendors and internal/external employees on processes related to Adverse Event reporting and use of Ascendis Safety Database. Serve as PV advisor to Ascendis Clinical Development Organizations, Medical Affairs, Commercial, and PV staff as applicable. Identify opportunities for process improvements and participate in process optimization initiatives; support signal detection, risk management, and health authority responses as needed. Raise awareness of PV requirements through education/training sessions with partners and vendors. Support Case Transmission Verification (CTV) and SAE Reconciliation activities as needed. Collaborate with PV IT on the Global Safety Database implementation/maintenance and safety reporting rules; review Business Partner or PV-related agreements to ensure safety exchange requirements are met. Additional activities
Contribute to the maintenance of Ascendis Pharmacovigilance System Master File (PSMF). Represent PV during regulatory inspections or internal quality audits in coordination with GCP and PV Compliance teams. Work with Vendor Management, Study Management, QPPV Office, and Medical Safety Science teams for assigned activities. Coordinate US Risk Management Plan implementations and related tracking as necessary. Maintain oversight of activities within the scope of Ascendis PV under the Head, ICSR Management, including local PV agreements and related activities. Participate in relevant crisis management activities within the scope of Ascendis PV. Qualifications
Bachelor’s degree in a health care field with relevant pharmaceutical industry experience in drug safety; advanced scientific degrees and extensive drug safety experience are highly desired. Minimum of 8 years of recent Pharmacovigilance experience. 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. Compensation and Benefits
The estimated salary range for this position is $180-195k. Actual salary determination is dependent on experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus or incentive compensation plan, discretionary stock-based long-term incentives, paid time off, and a comprehensive benefits package. 401(k) plan with company match Medical, dental, and vision plans Company-provided Life and AD&D insurance Company-provided short- and long-term disability benefits Pet Insurance and Legal Insurance Employee Assistance Program Employee Discounts Professional Development Health Savings Account (HSA) and Flexible Spending Accounts Various incentive compensation plans Additional insurance options for accident, critical illness, and hospital indemnity Mental Health resources Paid leave benefits for new parents Notes for Recruiters
We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.
#J-18808-Ljbffr
The Associate Director, ICSR Management Team reports to the Director, Head, ICSR Management within the Global Patient Safety (GPS) organization. Under the direction of the Head, ICSR Management, this role 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. Oversee operational activities of ICSRs processed by PV Vendor and provide feedback and guidance as applicable. Assist in the oversight of 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 and provide input to assigned vendors to improve Adverse Event intake quality. Perform late case investigation and risk mitigation; review late cases to determine Root Cause Analysis (RCA) and create 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. Identify and address non-compliance or late ICSRs 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. Collaborate with other functional groups for cross-functional PV process implementation and updates to SOPs/Work Instructions as applicable. Identify and develop training documents for targeted audiences and train GxP vendors and internal/external employees on processes related to Adverse Event reporting and use of Ascendis Safety Database. Serve as PV advisor to Ascendis Clinical Development Organizations, Medical Affairs, Commercial, and PV staff as applicable. Identify opportunities for process improvements and participate in process optimization initiatives; support signal detection, risk management, and health authority responses as needed. Raise awareness of PV requirements through education/training sessions with partners and vendors. Support Case Transmission Verification (CTV) and SAE Reconciliation activities as needed. Collaborate with PV IT on the Global Safety Database implementation/maintenance and safety reporting rules; review Business Partner or PV-related agreements to ensure safety exchange requirements are met. Additional activities
Contribute to the maintenance of Ascendis Pharmacovigilance System Master File (PSMF). Represent PV during regulatory inspections or internal quality audits in coordination with GCP and PV Compliance teams. Work with Vendor Management, Study Management, QPPV Office, and Medical Safety Science teams for assigned activities. Coordinate US Risk Management Plan implementations and related tracking as necessary. Maintain oversight of activities within the scope of Ascendis PV under the Head, ICSR Management, including local PV agreements and related activities. Participate in relevant crisis management activities within the scope of Ascendis PV. Qualifications
Bachelor’s degree in a health care field with relevant pharmaceutical industry experience in drug safety; advanced scientific degrees and extensive drug safety experience are highly desired. Minimum of 8 years of recent Pharmacovigilance experience. 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. Compensation and Benefits
The estimated salary range for this position is $180-195k. Actual salary determination is dependent on experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus or incentive compensation plan, discretionary stock-based long-term incentives, paid time off, and a comprehensive benefits package. 401(k) plan with company match Medical, dental, and vision plans Company-provided Life and AD&D insurance Company-provided short- and long-term disability benefits Pet Insurance and Legal Insurance Employee Assistance Program Employee Discounts Professional Development Health Savings Account (HSA) and Flexible Spending Accounts Various incentive compensation plans Additional insurance options for accident, critical illness, and hospital indemnity Mental Health resources Paid leave benefits for new parents Notes for Recruiters
We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.
#J-18808-Ljbffr