Ascendis Pharma · 4 months ago
ICSR Management Lead-Contractor - Job ID: ICSRC
Palo Alto, CA
Contract
Onsite
Mid Level
$75/hr - $90/hr
4+ years expAscendis Pharma is a dynamic, fast-growing global biopharmaceutical company advancing programs in Endocrinology Rare Disease and Oncology. They are seeking a contract ICSR Management Lead to oversee ICSR processing workflow management, submission, and follow-up activities while ensuring compliance with regulatory guidelines and managing vendor relationships.
BiotechnologyClinical TrialsHealth Care
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:
Ensures 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, Healthy 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. Assists in the oversight of the PV Vendor processing ICSRs for Ascendis Products
Performs Quality Checks of processed ICSRs and provides feedback to PV Vendor as applicable
Provides input to assigned vendors to improve the quality of Adverse Event intake
Performs 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
Supports with the oversight of 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
Drafts and updates departmental SOPs, Work Instruction etc. as applicable and ensure compliance with regulatory guidelines and regulations
Responsible for training GxP vendors on processes corresponding to identification and reporting of Adverse Events to Ascendis Global Patient Safety
Functions as a PV advisor to Ascendis Clinical Development Organizations, Medical Affairs, Commercial Organizations and PV staff as applicable
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
Supports Case Transmission Verification (CTV) and SAE Reconciliation activities as needed
Assists with collaboration with PV Information Technology team on implementation and maintenance of the Global Safety Database and Safety Reporting rules within the Safety Database
Qualification
Required
Bachelor's degree in a health care field with relevant pharmaceutical industry experience in drug safety
Minimum of 4 years recent experience in Pharmacovigilance
Working knowledge of validated Drug Safety Databases (Argus preferred)
Experience with MedDRA coding and global safety reporting regulatory requirements
Working knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations
Potentially may require travel up to 20% of the time domestically and internationally
Preferred
Candidates with advanced scientific degrees and extensive drug safety experience is highly desired
Benefits
Benefits will be dependent on role and provided by the employer of record for this contract role.
Company
Ascendis Pharma
Ascendis Pharma built a high-value pipeline that aims to change the clinical treatment paradigms.
1001-5000 employees
H1B Sponsorship
Ascendis Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (6)
2022 (4)
2021 (3)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.88BKey Investors
Royalty Pharma
2024-09-19Post Ipo Equity· $300M
2024-09-03Post Ipo Debt· $150M
2023-09-05Post Ipo Debt· $150M
Leadership Team
Ivanna Rosendal
Senior Director, IT Business Partner
Keren Tenenbaum
US General Counsel and Chief Compliance Officer
Recent News
2026-01-11
2026-01-11
Company data provided by crunchbase