Akcea Therapeutics, Inc. is a development and commercialization company focused on impacting the lives of patients with serious cardiometabolic lipid disorders. Our priority is to bring important new therapeutics to patients in need. In order to do so, we
must drive clinical program execution, understand patient and physician needs and work with regulators to gain global approval and market access to these new therapeutics.
Established as a subsidiary of Ionis Pharmaceuticals, Inc. in late 2014 and based in Cambridge, Massachusetts, Akcea was founded with a portfolio of development-stage drugs covering multiple targets and disease states using advanced antisense therapeutics.
In July 2017, Akcea closed its initial public offering of common stock and is listed on the NASDAQ Global Select Market under the symbol “AKCA.”
Senior Director, Global Pharmacovigilance (PV) Operations & Quality Management (QM)
The Senior Director, Global PV Operations & QM in the PV and Drug Safety (DS) department will report to the VP of PV & DS and be responsible for successful implementation of the global PV operations plan to ensure productivity, quality and compliance with
worldwide safety regulations. Strategic and tactical leadership oversight will cover clinical development and postmarketing activities, regional/country activities and PV vendors. This position requires ability to influence without directly managing and partnership
with colleagues in matrix teams and with senior management.
The requirements for the position include a Life Sciences Degree graduate and significant experience in the pharmaceutical and/or biotechnology industry. The ideal candidate will be an individual with experience of successfully leading global PV operations.
This position will require a PV leader who can be actively engaged in day-to-day activities.
- Provide vendor oversight for outsourced global PV operations, case management and quality management activities for both investigational and commercial products.
- Produce and maintain integrated global strategic PV operations plan and oversee its successful implementation across regions and countries.
- Produce clear standards and documentation for Akcea working with the PV vendor as basis for a high quality pharmacovigilance system.
- Produce high quality expedited (MedWatch/CIOMS) and periodic safety reports for investigational (DSUR) and commercial products (PSUR/PBRER).
- Oversee the PV quality management system including setting standards, training requirements, monitoring performance, implementing continuous improvement actions and good documentation practices. Work with QA department to produce the pharmacovigilance audit
plan and maintain a state of high PV inspection readiness across all regions/countries.
- Produce global PV operations budget and manage resources to budget.
- Spokesperson for global PV operations in company cross-functional matrix teams.
- Provide PV operations support for signal detection and risk management planning activities.
- Contribute to regulatory filing activities related to product safety and risk management.
- Contribute to medical information activities related to product safety and risk management.
- Provide leadership for attracting talent and growing the global PV operations function in Akcea.
- Lead change and continuous improvement activities in global PV operations and participate in external benchmarking activities to ensure best PV practices in the company.
Qualifications and Experience
- Life Science Degree or Healthcare professional.
- Minimum of 10 years’ experience in PV operations.
- Experience in a global pharma organization.
- Experience in supervising and managing PV personnel involved in global case management, aggregate reporting and QM activities.
- Experience in leading global systems change.
- Extensive experience in performance management of PV systems.
- Expert knowledge of GVP and FDA and EU legislation and ICH PV guidelines.
- Experience with regulatory inspections and company audits including MHRA/EMA PV inspections.
Key Skills, Abilities, and Competencies
- Systems thinking ability and leadership of global systems change.
- Ability to produce documented procedures (SOPs), system maps and contribute to written regulatory responses.
- Excellent interpersonal, verbal and written communication skills.
- Proven ability to lead a cross-functional, matrixed team.
- Ability to manage global projects.
- Excellent organizational skills and the ability to apply extreme attention to detail and organization in all aspects of work.
- Solid knowledge of PV with a general understanding of the drug development process.
Other Job Requirements
- Travel, domestic and international, likely to be ~20%.
Excellent salary and benefits package offered.
For more information on Akcea and to apply for this position, please visit our website:
www.akceatx.com Reference #xxxxx
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Akcea Therapeutics, Inc. is proud to be an EEO employer.