Reporting to the Sr.
Director of Drug Safety & Pharmacovigilance Operations, the Director of Drug Safety and Pharmacovigilance Compliance, Training & Infrastructure is responsible for the management and oversight of pharmacovigilance (PV) quality and compliance across the PV system, PV inspections and audits, PV activities including QC of aggregate reports and metrics, partner relationship management, PV training and education, and CRO and vendor management.
The successful candidate will be responsible for ensuring compliance with regulatory requirements and corporate and departmental procedures.
This position requires ability to influence without directly managing and partnership with internal and external colleagues in matrix teams and with senior management.
Required Skills
Key responsibilities include:
- Oversight of pharmacovigilance (PV) quality and compliance system including establishing standards, department training requirements, monitoring department performance, implementing continuous improvement actions and good documentation
- Collaboration with QA department to maintain a state of high PV inspection readiness across all regions/countries, provide support for inspections and
- Maintain high level of knowledge of current global pharmacovigilance regulations, updates to regulations and good pharmacovigilance practices.
- Partner with DSPV in the generation, review, approval and operational implementation of governing documents, such as SOPs and Work Instructions, as
- PV Vendor oversight, including key performance indicator (KPI) metrics generation and review, contract compliance, quality and timeliness of deliverables and continuous improvement.
PV vendors can include database providers, CROs and other vendors as needed.
- Ensure inspection readiness of vendors conducting PV activities through above-referenced KPI metrics review, vendor audit findings, CAPA generation and
- Provide functional support / input into PV vendor relationships including safety database holders, CROs and other vendors as required (e.g., business requirements, vendor selection, contract details).
- Support partner relationships through participation in Joint Pharmacovigilance Committees; generate and maintain Safety Data Exchange Agreements, as necessary; partner with PV Operations with regard to operational implementation of SDEAs/PVAs.
- Provide support for department activities, including but not limited to review of core documents including Investigator Brochure (IB), protocols and aggregate
- Provide program management support for department initiatives, including activities required in preparation for product launch.
- Provide pharmacovigilance training and training documentation for investigator meetings, vendors, CROs and partners, as
- Includes direct supervision and management of internal safety infrastructure personnel.
- Other responsibilities as needed
Required Experience
Basic Qualifications
- BS degree
- Experience in Drug Safety, Clinical or R/D or the equivalent and preferred previous experience in management of people.
Preferred Qualifications
- 8-10 years of experience in Drug Safety/Pharmacovigilance quality and compliance in pharma/biotech space
- Prior management experience
- Master’s or Doctorate level degree in health care related profession
- Minimum 5 years’ experience working with CROs, vendors, and relationship management preferred
- Successful leadership / senior level experience in global pharmacovigilance quality and compliance
- Extensive experience in performance management of PV
- Experience with regulatory inspections and company audits including MHRA/EMA PV inspections
Skills and Experience
- Strong experience with safety databases, clinical databases and data evaluation tools (e.g., Oracle Argus, Medidata, eClinical).
- Exhibits leadership skills that promotes team collaboration, fosters open dialog, maintains an inclusive collaborative environment, keeps a team focused on a common goal and maintains positive momentum through
- Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an
- Proven ability to lead a cross-functional, matrixed
- Expert knowledge of FDA and EU legislation and ICH PV
- Prior NDA / MAA experience
All Akebia new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief.
Requests for accommodation will be considered on a case-by-case basis, and Akebia will consider, among other things whether a proposed accommodation would create an undue hardship.
Are you an Akebian?
An Akebian is curious, empathetic, and values making connections to people and ideas.
Akebian’s aren’t afraid of diving in and owning a process or a problem, because we all want to deliver a great solution.
Akebian’s believe that we are better together because we are all working toward a common purpose – to better the life of each person impacted by kidney disease.
Akebia is an equal opportunity employer and welcomes all job applicants.
All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.