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.
We are seeking a contract ICSR Lead to help cover a leave of absence.
The ICSR Management Lead reports to the Head, ICSR Management 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.
Key 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.
Competencies Identified for success:
- Works effectively, independently, and collaboratively
- Strong organizational skills, 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
- Sound strategic evaluation, analysis, and decision-making skills as 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 is highly desired.
- 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
Estimated Hourly Pay: $75-90/hr DOE.
Actual pay determination is dependent on a variety of factors some of which include: experience, qualifications, and geographic location. This position may be eligible for a limited benefits in accordance with plan offerings of contract employment firm.
Benefits
Benefits will be dependent on role and provided by the employer of record for this contract role.
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.
