Reporting to the Sr. Director of Operations, Drug Safety and Pharmacovigilance (DSPV), the Associate Director, DSPV will play a key role in the Drug Safety and Pharmacovigilance Operations across the Postmarketing and Clinical Development program.
The Associate Director, DSPV Operations provides leadership through independently managing the operational activities both internally and through a third-party Pharmacovigilance contract vendor related to the processing of adverse events from clinical trials and Postmarketing surveillance and ensures that performed tasks comply with DSPV SOPs and procedures, best industry standards and applicable regulations.
Required Skills
- Independently manages the third-party Pharmacovigilance vendor outsourced Clinical Trial and Postmarketing Surveillance activities.
- Provides sponsor oversight of SAE processing by outsourced vendors, including the review and monitoring of compliance through various monitoring reports and other oversight activities and ensures the implementation of effective corrective and preventative action plans.
- Participates in the review and execution of DSPV Operations safety data collection and processing and execution strategy across programs.
- Maintains knowledge of adverse event reporting process and safety system and contributes to the development, implementation, improvement, and standardization of new processes, methods, and databases.
- Actively participates in the quality review of SAEs and SUSARs following data entry by vendor. Specific focus on accuracy of narrative to reflect source documentation, MedDRA coding, and appropriateness of queries to seek follow-up from the clinical sites.
- Represents DSPV on clinical development teams, as assigned.
- Collaborates with contract service providers regarding adverse event reporting for Postmarketing Surveillance activities as required.
- Collaborates with Medical Affairs personnel on Investigator Sponsored Research programs as required.
- Ensures compliant exchange of safety data between Akebia and its partners.
- Participates in the creation and dissemination of appropriate safety reporting language in clinical trial key documents.
- Participates in authoring and QC of periodic safety reports (e.g., DSUR, PSUR, IND annual reports)
- Provides safety operations support for external submissions, signal detection and risk management planning activities.
- Authors governing documents, such as SOPs, Work Instructions and Safety Management Plans.
- Monitors compliance with regulations, PV agreements and internal SOPs.
- Participates in the quality management system in Drug Safety including ensuring department standards are met, including training requirements, monitoring performance, implementing continuous improvement actions and good documentation practices.
- Works with QA department to maintain a state of high PV inspection readiness across all regions/countries.
- Participates in internal audits and global regulatory inspections including MHRA/FDA/EMA etc. as a SME for specific PV topics and processes.
- Contributes to formal responses to inspection and audit findings related to DSPV department.
- Supervision and direct management of internal safety operations personnel as the department expands.
- Assists in performing additional ad hoc activities as assigned.
- Collaborates with Medical Affairs personnel on Investigator Sponsored Research programs as required.
- Ensures compliant exchange of safety data between Akebia and its partners.
- Participates in the creation and dissemination of appropriate safety reporting language in clinical trial key documents.
- Participates in authoring and QC of periodic safety reports (e.g., DSUR, PSUR, IND annual reports)
- Provides safety operations support for external submissions, signal detection and risk management planning activities.
- Authors governing documents, such as SOPs, Work Instructions and Safety Management Plans.
- Monitors compliance with regulations, PV agreements and internal SOPs.
- Participates in the quality management system in Drug Safety including ensuring department standards are met, including training requirements, monitoring performance, implementing continuous improvement actions and good documentation practices.
- Works with QA department to maintain a state of high PV inspection readiness across all regions/countries.
- Participates in internal audits and global regulatory inspections including MHRA/FDA/EMA etc. as a SME for specific PV topics and processes.
- Contributes to formal responses to inspection and audit findings related to DSPV department.
- Supervision and direct management of internal safety operations personnel as the department expands.
- Assists in performing additional ad hoc activities as assigned.
Required Experience
BASIC QUALIFICATIONS:
- Bachelor’s degree in nursing, pharmacy, or other health care related profession or life sciences preferred or equivalent qualification/work experience.
- Minimum of 3-5 years of experience in Drug Safety/Pharmacovigilance in a pharmaceutical industry setting or the equivalent.
- Minimum of 2 years of experience managing with third-party Pharmacovigilance vendors, CROs, and business alliance relationship management.
- Minimum of 2 years managing direct reports.
PREFERRED QUALIFICATIONS:
- Global pharmacovigilance operations experience with marketed products and/or products in development.
- Knowledge of relevant ICH, European Commission, and FDA Guidance and Regulations governing adverse event processing and reporting from clinical trials and/or Postmarketing surveillance.
- Experience working with Safety databases and systems (Argus preferred)
- Experience with MedDRA coding and data entry.
- Strong analytical and problem-solving skills with superb attention to detail.
- Strong verbal, written technical communication and presentation skills.
- Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization.
- Proven ability to work within a cross-functional, matrixed team with the ability to manage multiple tasks with competing timelines.
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com.
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.