||Head, Drug Safety and Pharmacovigilance
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 wholly-owned subsidiary of Ionis Pharmaceuticals, Inc. in late 2014 and based in Cambridge, Massachusetts, Akcea was founded with a robust portfolio of development-stage drugs covering multiple targets and disease states using advanced antisense
Head, Drug Safety And Pharmacovigilance
Akcea has drugs in all phases of clinical development and is looking for an experienced Safety and Pharmacovigilance Physician to join us in our Cambridge, MA, offices and build and lead our drug safety programs.
- Develop and lead all pharmacovigliance activities for clinical development and commercial products
- Take charge of the collection, collation, evaluation and distribution of safety reports, the preparation and submission of aggregate reports, data management, signal detection and risk management.
- Select and manage relevant CRO and vendors
- Ensure compliance with major national and international Pharmacovigilance regulations
- Build and maintain a pharmacovigilance quality system
- Ensure functional and compliance training in Safety of all relevant company staff
- Generate mandated safety reports (DSUR, PSURs) and manage signal detection activities
- Build a collaborative relationship with the Safety function and leadership at Ionis
- Ensure qualified medical review and analysis of reports during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigation of products
- Manage ongoing safety surveillance and signal detection/analysis
- Provide medical guidance to Drug Safety Associates and relevant employees in medical aspects of drug safety
- Provide pre-submission expert review on all relevant clinical, safety and regulatory documents
- Function as pharmacovigilance representative on internal and partnered programs
- Ensure senior management is made aware in a timely manner of any important safety signals or events
- Reports to: The Chief Medical Officer
- All aspects of the Drug Safety and Pharmacovigilance function
- Quality, Operational and Compliance
- Review and approval of Safety-related submission documents:
- Clinical study reports
- Study protocols
- Clinical Trial (Serious) Adverse Event Reports
- Case files, narratives, coding, causality and expectedness assessment
- Analysis of Adverse Event Reports during ongoing surveillance and signal detection, including independent analysis of safety risks
- Support of study DSMBs by provision of requested Safety data and analyses
- Writing of safety section, including benefit risk assessment, of DSURs, annual reports, and RMPs
- Attend and present material (such as therapeutic area training), as requested, at internal and external meetings (such as investigator meetings)
The successful candidate will possess:
- Medical Degree (MD/DO), preferably board certified in internal medicine
- 10+ years of experience in pharmacovigilance gained in pharmaceutical industry
- 5+ years of management experience in Pharmacovigilance and/or Drug Safety
- A successful track record of high productivity and quality of work
- Proficiency in relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments (including ICH/CIOMS, Clinical development methodology and knowledge of Clinical Trial guidelines
(GCP) and regulation) is essential.
- Working knowledge of MedDRA dictionary is necessary
- Familiarity with common Safety databases (e.g. ARIS, etc.) is preferred
- Knowledge of Individual Case Safety Reports (ICSR) management processes including case receipt, case processing, medical review and regulatory submission
- Proven ability to work on multiple projects
- Action orientation combined with high ethical standards is critical
- Efficiency, detail-oriented orientation, flexibility and the ability to meet tight deadlines is essential
- Excellent communication, organizational, planning, and follow-up skills are needed
Excellent salary and benefits package offered.
Please visit our website, www.akceatx.com, to apply for this position. Reference Requisition #15-0107
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and Akcea Therapeutics, Inc. are proud to be EEO employers.
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