Ascendis Pharma
Associate Director, ICSR Management Team - Job ID: 1755CA
Ascendis Pharma, Palo Alto, California, United States, 94306
Associate Director, ICSR Management Team (Job ID: 1755CA)
Ascendis Pharma is a dynamic, fast‑growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. We advance programs in Endocrinology Rare Disease and Oncology, using our TransCon® drug development platform to develop new and potentially best‑in‑class therapies for unmet medical needs.
Key Responsibilities
Act as a subject matter expert on ICSR processing and provide strategic input on case processing activities for Ascendis products.
Ensure all safety reports from any source for Ascendis products are processed in the safety database and reported according to ICH‑GCP guidelines, Health Authority regulations, and company SOPs, work instructions, and business partner agreements.
Oversee operational activities of PCSRs processed by the PV vendor, providing feedback and guidance as required and assisting with oversight of the PV vendor’s processing of ACSRs for Ascendis products.
Perform quality checks of processed ACSRs and provide feedback to the 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.
Conduct late case investigations and risk mitigation strategy, including root cause analysis and creation of corrective and preventative actions (CAPA) as applicable.
Oversee regulatory and departmental compliance by ensuring timely processing of ACSRs in the safety database and submission to health authorities or partners as required.
Identify non‑compliance or late ACSRs 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, and other documentation as applicable, ensuring compliance with regulatory guidelines.
Identify and develop training documents for the targeted audience (as needed) and train GxP vendors on processes related to identification and reporting of adverse events.
Train internal and external employees on the use of the Ascendis safety database as assigned.
Serve as a PV advisor to Ascendis clinical development, medical affairs, commercial organizations, and PV staff.
Identify opportunities for process improvements and participate in process optimization initiatives.
Support the medical safety science team with activities related to signal detection, risk management, and health authority responses as needed.
Raise awareness and understanding of pharmacovigilance requirements by conducting education and training sessions with functional partners and vendors as required.
Support case transmission verification (CTV) and SAE reconciliation activities as needed.
Collaborate with the 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.
Additional Activities (may include but not limited to)
Contribute to the maintenance of the Ascendis pharmacovigilance system master file (PSMF).
Coordinate with the Ascendis GCP and PV compliance team to provide appropriate representation during PV‑related regulatory inspections or internal quality assurance/corporate compliance audits.
Work collaboratively with vendor management, study management, QPPV office, and medical safety science teams for assigned activities.
Serve as the lead for US‑applicable risk management plan implementation coordination activities and associated tracking as necessary.
Maintain selected oversight of activities within the scope of the Ascendis PV group under the direction of the Head of ICSR management, such as local PV agreements, CRMs, digital media, etc.
Participate in relevant crisis management activities within the scope of the Ascendis PV group.
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, encouraging collaboration in a multidisciplinary setting.
Excellent written and verbal communication skills, with credibility and confidence.
Sound strategic evaluation, analysis, and decision‑making skills demonstrated in effective strategy formulation, tactics, and action plans to achieve results.
Displays a high level of commitment.
Requirements
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 are 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.
The estimated salary range for this position is $180‑195k. Actual salary determination is dependent on a variety of factors, including 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.
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
Pet and legal insurance
Employee assistance program
Employee discounts
Professional development opportunities
Health savings 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
Seniority Level Mid‑Senior level.
Employment Type Full‑time.
Job Function Business Development and Sales. Pharmaceutical manufacturing industry.
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Key Responsibilities
Act as a subject matter expert on ICSR processing and provide strategic input on case processing activities for Ascendis products.
Ensure all safety reports from any source for Ascendis products are processed in the safety database and reported according to ICH‑GCP guidelines, Health Authority regulations, and company SOPs, work instructions, and business partner agreements.
Oversee operational activities of PCSRs processed by the PV vendor, providing feedback and guidance as required and assisting with oversight of the PV vendor’s processing of ACSRs for Ascendis products.
Perform quality checks of processed ACSRs and provide feedback to the 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.
Conduct late case investigations and risk mitigation strategy, including root cause analysis and creation of corrective and preventative actions (CAPA) as applicable.
Oversee regulatory and departmental compliance by ensuring timely processing of ACSRs in the safety database and submission to health authorities or partners as required.
Identify non‑compliance or late ACSRs 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, and other documentation as applicable, ensuring compliance with regulatory guidelines.
Identify and develop training documents for the targeted audience (as needed) and train GxP vendors on processes related to identification and reporting of adverse events.
Train internal and external employees on the use of the Ascendis safety database as assigned.
Serve as a PV advisor to Ascendis clinical development, medical affairs, commercial organizations, and PV staff.
Identify opportunities for process improvements and participate in process optimization initiatives.
Support the medical safety science team with activities related to signal detection, risk management, and health authority responses as needed.
Raise awareness and understanding of pharmacovigilance requirements by conducting education and training sessions with functional partners and vendors as required.
Support case transmission verification (CTV) and SAE reconciliation activities as needed.
Collaborate with the 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.
Additional Activities (may include but not limited to)
Contribute to the maintenance of the Ascendis pharmacovigilance system master file (PSMF).
Coordinate with the Ascendis GCP and PV compliance team to provide appropriate representation during PV‑related regulatory inspections or internal quality assurance/corporate compliance audits.
Work collaboratively with vendor management, study management, QPPV office, and medical safety science teams for assigned activities.
Serve as the lead for US‑applicable risk management plan implementation coordination activities and associated tracking as necessary.
Maintain selected oversight of activities within the scope of the Ascendis PV group under the direction of the Head of ICSR management, such as local PV agreements, CRMs, digital media, etc.
Participate in relevant crisis management activities within the scope of the Ascendis PV group.
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, encouraging collaboration in a multidisciplinary setting.
Excellent written and verbal communication skills, with credibility and confidence.
Sound strategic evaluation, analysis, and decision‑making skills demonstrated in effective strategy formulation, tactics, and action plans to achieve results.
Displays a high level of commitment.
Requirements
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 are 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.
The estimated salary range for this position is $180‑195k. Actual salary determination is dependent on a variety of factors, including 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.
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
Pet and legal insurance
Employee assistance program
Employee discounts
Professional development opportunities
Health savings 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
Seniority Level Mid‑Senior level.
Employment Type Full‑time.
Job Function Business Development and Sales. Pharmaceutical manufacturing industry.
#J-18808-Ljbffr