Overview
Executive Director Jobs in Pawnee, OK at Ascension Recovery Services
Role Summary:
The Senior Director/Executive Director of Quality Assurance, Pharmacovigilance (PV) is responsible for partnering with the Leader of Pharmacovigilance to assure their strategy and execution ingrains quality and compliance across all aspects of product safety across clinical development and post-marketing surveillance. This role is instrumental in applying a risk based approach to ensure that PV activities align with regulatory requirements and company standards. Additionally, this position would represent QA to identify risks, resolve issues, and escalates appropriately to ensure the safe use of products globally. This leader should demonstrate a high level of independent quality judgement and acumen.
Key Responsibilities:
In partnership with the Pharmacovigilance (PV) colleagues, drive strategy and execution of the following:
Establish and maintain a compliant QA oversight program for PV data and ensure compliance with reporting standards and company policies.
Perform periodic regulatory intelligence on new Health Authority policies and industry standards that impact PV. Understand and implement changes to maintain compliance.
Provide Quality Assurance leadership and Subject Matter Expertise (SME) for Good Pharmacovigilance Practices (GVP) to pharmacovigilance teams
Provide QA oversight for end-to-end PV activities, including case processing, safety surveillance, risk management, and signal detection and assessment.
Drive a risk based approach to PV activities, with appropriate metrics and trending.
Responsible for inspection readiness related to GVP
Provide QA oversight of safety aspects of regulatory submissions, periodic safety reports (e.g., DSURs, PSURs, RMPs), and responses to regulatory inquiries.
Ensure risk management/reduction strategies are developed and included in relevant documents such as clinical study protocols.
Support inspection readiness activities including audits and inspections conducted by external sources as applicable
Author and maintain QA Standard Operating Procedures (SOPs) as necessary. Support management of other functional area SOPs
Lead process improvement projects as needed
Scope of Oversight Reponsibilities:
Provide Quality oversight for PV related documents, such as not limited to the following:
Local Individual Case Safety Reports (ICSR)
Local Product Safety Master File (L-PSMF)
Risk Management Plan and implementation of additional Risk Minimization Measure
Local Periodic Safety Update Report (PSUR)/Aggregate Report Management
Product Labeling Changes
Regulatory Authority Communication
Pharmacovigilance Training
Pharmacovigilance Business Continuity Plan (BCP)
Signal Management and Benefit Risk Assessment
Urgent Safety Alert support
Pharmacovigilance Audit and Inspection
Compliance monitoring and metrics
Pharmacovigilance data archiving
Corrective and Preventive Action (CAPA)
Required Skills and Experience:
Demonstrated ability to provide QA oversight of Serious Adverse Event (SAE) processing and ensure timely, compliant, and accurate safety reporting in accordance with applicable regulatory requirements, Good Clinical Practice (GCP), and standard operating procedures (SOP).
Possesses expert knowledge of current ICH and health authority requirements, expectations, and trends in patient safety and pharmacovigilance, and ensure compliance in all activities. Ensure readiness for health authority inspections and partner audits.
Excellent verbal, written, and presentation communication skills, ability to work with cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and advocating compliance.
Demonstrated knowledge and thorough understanding of GVP in accordance with US/MHRA/EU/ROW Health Authority regulations, and industry standards such as ICH for the pharmaceutical industry.
Ability to use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways.
Ability to deal with ambiguity, and provide creative and pragmatic solutions to issues and risks.
In-depth knowledge of global pharmacovigilance regulations and guidelines, including FDA, EMA, and ICH.
Strong understanding of clinical development, post-marketing safety, and regulatory submissions
Experience interacting with global regulatory authorities and scientific advisory bodies.
Exceptional leadership, strategic thinking, and communication skills.
Bachelor’s in a related discipline (STEM, pharmacy, medical, etc.) and 10 years of related experience, or Master’s in a related discipline (STEM, pharmacy, medical, etc.) and 8 years of related experience, or Doctorate in a related discipline (STEM, pharmacy, medical, etc.) and 5 years of related experience.
Work Schedule and Location:
This role will be remote within the United States. Occassional travel to the corporate office outside of Philadelphia, PA and vendor/partner sites will be required. The employee must be able to work a US eastern time schedule.
Savara provides comprehensive benefits including:
Highly competitive medical, dental, and vision coverage
Flexible Spending Accounts for health care and dependent care expenses
Paid time off and paid holidays, including Dec 24-Jan 1
Paid parental leave
401k with highly competitive match
Life, AD&D, STD and LTD insurance coverage
Savara’s compensation can include a base salary, bonus, and equity. This role is posted as either a Senior Director or Executive Director and the expected compensation range $200,000 to $275,000.
About Savara:
Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. The company’s lead program, molgramostim nebulizer solution, is in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Savara’s management team has extensive experience in rare respiratory diseases and pulmonary medicine, advancing product candidates to approval and commercialization.
Savara is an equal opportunity employer.
Title: Executive Director
Company: Ascension Recovery Services
Location: Pawnee, OK
