Associate Director, ICSR Management Team - Job ID: 1755NJ
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 Associate Director, ICSR Management Team reports to the Director, Head, ICSR Management Team 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.
- Coordinates follow up activities for missing or ambiguous safety information as appropriate.
- Support vendor oversight by monitoring performance metrics/KPIs.
- 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.
- Oversee 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.
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- 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.
- Drafts and updates departmental SOPs, Work Instruction etc. as applicable and ensure compliance with regulatory guidelines and regulations.
- Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience (as needed)
- Responsible for training GxP vendors on processes corresponding to identification and reporting of Adverse Events to Ascendis Global Patient Safety.
- Responsible for training Internal and External employees on the use of Ascendis Safety Database as assigned.
- Functions as a PV advisor to Ascendis Clinical Development Organizations, Medical Affairs, Commercial Organizations and PV staff as applicable.
- Identify opportunities for process improvements and participate in process optimization initiatives.
- 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.
- Collaborate with PV Information Technology team on implementation and maintenance of the Global Safety Database and Safety Reporting rules within the Safety Database.
- Reviews and provides 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 are not limited to:
- Contribute to the maintenance of Ascendis Pharmacovigilance System Master File (PSMF)
- Through coordination with Ascendis GCP and PV Compliance team will 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
- Is responsible for any assigned US applicable Risk Management Plan Implementation Coordination activities and associated tracking as necessary
- Maintain selected oversight of activities within the scope of Ascendis PV group under the direction of Head, ICSR management (example: Local PV agreements, CRMs, Digital Media etc.)
- Participate in relevant crisis management activities within the scope of Ascendis PV group
Competencies Identified for success:
- Works effectively, independently, and collaboratively
- Strong organizational skills, detail oriented and adapts in a dynamic, fast paced environment
- Demonstrates ownership, initiative, and accountability
- Ability to interact as an effective team player encouraging collaboration in a multifunctional and multidisciplinary team setting
- Excellent communication skills, both written and verbal, with credibility and confidence
- 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 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 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
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.