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.The Manager, ICSR Management Team reports to the Director, Head, ICSR Management within the Global Patient Safety (GPS) organization. Under the direction of the Director, Head, ICSR Management, is responsible for all assigned ICSR Management activities including ICSR processing workflow management, submission and follow-up activities. Act as a Subject Matter Expert (SME) with regards to processing of Individual Case Safety Reports (ICSRs)Ensure that all safety reports received from any source for Ascendis products are processed in the safety database and reported according to ICH-GCP guidelines, Health Authority regulations, company SOPs, Work Instructions and business partner agreements.Assist in the oversight of the PV vendor that processes ICSRs for Ascendis products.Participate in triage of incoming AE reports to identify cases of special interest and cases requiring expedited reporting to Health Authorities and business partners.Perform quality check of processed ICSRs and provide feedback to PV vendor.Perform quality review of information received from assigned vendors and provide feedback to improve the quality and completeness of source documentation.Ensure any non-compliance or late ICSR are identified and escalated to management. · Ensure integrity of safety database outputs used for aggregate reports, Health Authority requests or other safety requirements.· Liaise with other functional areas for implementation of PV related processes requiring cross functional collaboration.· Provide input into departmental SOPs and Work Instructions and ensure compliance with regulatory guidelines and regulations.· Provide input into training documents for the targeted audience.· Train vendors on processes for identifying and reporting Adverse Events to Ascendis Global Patient Safety (GPS).· Identify opportunities for process improvements and participate in optimization initiatives.· Support Case Transmission Verification (CTV) and SAE Reconciliation activities Additional activities may include but are not limited to:Work collaboratively with Vendor Management, Study Management, QPPV Office and Medical Science teams for assigned activitiesMaintain selected oversight of activities within the scope of Ascendis PV group under the direction of Head, ICSR ManagementParticipate in relevant crisis management activities within the scope of Ascendis PV group Competencies Identified for success:Works effectively, independently, and collaborativelyDisplays strong organizational skills, is detail oriented and adapts in a dynamic, fast paced environmentAbility to interact as an effective team player, encouraging collaboration in a multifunctional and multidisciplinary team settingExcellent communication skills, both written and verbalDisplays a high level of commitmentRequirementsBachelor’s degree in a health care field.Minimum 5 years recent clinical trial and post-marketing case processing experienceWorking knowledge of validated Drug Safety databases (Argus preferred)Experience with MedDRA coding and global safety reporting regulatory requirementsStrong foundational knowledge of FDA and EU safety regulations, GVP principles and ICH GuidelinesAbility to travel up to 20% of the time domestically and internationally This is a hybrid position, requiring physical presence in the Palo Alto, CA office 3 days per week. Relocation is not offered for this position and remote candidates will not be considered.The estimated salary range for this position is $150-160K. Actual salary determination is dependent on a variety of factors some of which include: experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus or an incentive compensation plan (eligibility varies based on role and position level), discretionary stock-based long-term incentives, paid time off, and a comprehensive benefits package.Benefits 401(k) plan with company match Medical, dental, and vision plans Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance Company-provided short and long-term disability benefits Unique offerings of Pet Insurance and Legal Insurance Employee Assistance Program Employee Discounts Professional Development Health Saving Account (HSA) Flexible Spending Accounts Various incentive compensation plans Accident, Critical Illness, and Hospital Indemnity Insurance Mental Health resources Paid leave benefits for new parents Ascendis Pharma is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees.A note to 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.
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.
The Manager, ICSR Management Team reports to the Director, Head, ICSR Management within the Global Patient Safety (GPS) organization. Under the direction of the Director, Head, ICSR Management, is responsible for all assigned ICSR Management activities including ICSR processing workflow management, submission and follow-up activities.
Act as a Subject Matter Expert (SME) with regards to processing of Individual Case Safety Reports (ICSRs)
- Ensure that all safety reports received from any source for Ascendis products are processed in the safety database and reported according to ICH-GCP guidelines, Health Authority regulations, company SOPs, Work Instructions and business partner agreements.
- Assist in the oversight of the PV vendor that processes ICSRs for Ascendis products.
- Participate in triage of incoming AE reports to identify cases of special interest and cases requiring expedited reporting to Health Authorities and business partners.
- Perform quality check of processed ICSRs and provide feedback to PV vendor.
- Perform quality review of information received from assigned vendors and provide feedback to improve the quality and completeness of source documentation.
- Ensure any non-compliance or late ICSR are identified and escalated to management.
· Ensure integrity of safety database outputs used for aggregate reports, Health Authority requests or other safety requirements.
· Liaise with other functional areas for implementation of PV related processes requiring cross functional collaboration.
· Provide input into departmental SOPs and Work Instructions and ensure compliance with regulatory guidelines and regulations.
· Provide input into training documents for the targeted audience.
· Train vendors on processes for identifying and reporting Adverse Events to Ascendis Global Patient Safety (GPS).
· Identify opportunities for process improvements and participate in optimization initiatives.
· Support Case Transmission Verification (CTV) and SAE Reconciliation activities
Additional activities may include but are not limited to:
- Work collaboratively with Vendor Management, Study Management, QPPV Office and Medical Science teams for assigned activities
- Maintain selected oversight of activities within the scope of Ascendis PV group under the direction of Head, ICSR Management
- Participate in relevant crisis management activities within the scope of Ascendis PV group
Competencies Identified for success:
- Works effectively, independently, and collaboratively
- Displays strong organizational skills, is detail oriented and adapts in a dynamic, fast paced environment
- Ability to interact as an effective team player, encouraging collaboration in a multifunctional and multidisciplinary team setting
- Excellent communication skills, both written and verbal
- Displays a high level of commitment
Requirements
- Bachelor’s degree in a health care field.
- Minimum 5 years recent clinical trial and post-marketing case processing experience
- Working knowledge of validated Drug Safety databases (Argus preferred)
- Experience with MedDRA coding and global safety reporting regulatory requirements
- Strong foundational knowledge of FDA and EU safety regulations, GVP principles and ICH Guidelines
- Ability to travel up to 20% of the time domestically and internationally
- This is a hybrid position, requiring physical presence in the Palo Alto, CA office 3 days per week.
Relocation is not offered for this position and remote candidates will not be considered.
The estimated salary range for this position is $150-160K. Actual salary determination is dependent on a variety of factors some of which include: experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus or an incentive compensation plan (eligibility varies based on role and position level), discretionary stock-based long-term incentives, paid time off, and a comprehensive benefits package.
Benefits
- 401(k) plan with company match
- Medical, dental, and vision plans
- Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
- Company-provided short and long-term disability benefits
- Unique offerings of Pet Insurance and Legal Insurance
- Employee Assistance Program
- Employee Discounts
- Professional Development
- Health Saving Account (HSA)
- Flexible Spending Accounts
- Various incentive compensation plans
- Accident, Critical Illness, and Hospital Indemnity Insurance
- Mental Health resources
- Paid leave benefits for new parents
Ascendis Pharma is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees.
A note to 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.
Founded in Copenhagen, Denmark in 2007, Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by our core values of patients, science and passion, we utilize our innovative TransCon™ technology platform to create new and potentially best-in-class therapies.Today, we’re advancing programs in Endocrinology Rare Disease, Oncology, and Ophthalmology. We currently have five product candidates in clinical development: three in Endocrinology Rare Disease and two in Oncology. In addition, Ascendis recently announced new pre-clinical programs in Ophthalmology. We are a dynamic, growing biopharma company with headquarters in Copenhagen and additional offices and research facilities in Germany (Heidelberg, Munich, and Berlin) and the United States (Palo Alto, California, and Princeton, New Jersey).
Founded in Copenhagen, Denmark in 2007, Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by our core values of patients, science and passion, we utilize our innovative TransCon™ technology platform to create new and potentially best-in-class therapies.
Today, we’re advancing programs in Endocrinology Rare Disease, Oncology, and Ophthalmology. We currently have five product candidates in clinical development: three in Endocrinology Rare Disease and two in Oncology. In addition, Ascendis recently announced new pre-clinical programs in Ophthalmology.
We are a dynamic, growing biopharma company with headquarters in Copenhagen and additional offices and research facilities in Germany (Heidelberg, Munich, and Berlin) and the United States (Palo Alto, California, and Princeton, New Jersey).
