Reporting to the Associate Director of Safety Science, the Drug Safety & Pharmacovigilance Scientist works collaboratively with Medical Safety, other DSPV staff, and cross-functional colleagues/teams to perform safety surveillance activities and provide scientific/clinical PV expertise with a focus on the identification, evaluation and management of safety risks for assigned marketed and investigational products throughout the products’ lifecycle(s).
The primary function of the Drug Safety & Pharmacovigilance Scientist is to actively support Akebia’s focus on patient safety by performing and contributing to safety monitoring, the aggregate review and reporting of safety information in support of regulatory and partner reporting requirements, as well as safety surveillance and risk management activities pertaining to Akebia products.
Required Skills
- Active participation on DSPV safety surveillance teams and activities including performing case series review or review of tabulated data and prepare draft interpretation of reviewed data for identifying and assessing safety signals and adequately documenting discussions and conclusions
- Project manage signal detection activities including the searching of databases, literature, and other sources of data, preparing safety signal reports for DSPV Evaluation, and performing ad hoc analyses as required
- Collaborate with and support study teams and other applicable Akebia functional area specialists including (but not limited to) Clinical, Medical, Biostatistics, Medical Affairs, Quality, Regulatory Affairs to identify, evaluate and manage safety signals for Akebia marketed and investigational products to optimally support alignment in the understanding and interpretation of safety data
- Draft and author responses and safety documents for both internal and external bodies including regulatory filings and other mandated reviews of safety. Documents include, but not limited to the IB, CCSD/CCSI, DSUR, PSUR, RMP, PBRER, NDA, MAA, JNDA and others upon request.
- Lead and/or support the risk management documents, including Risk Management Plans and Risk Minimization Plans or REMS for submission to regulatory agencies. Assists in the evaluation of risk minimization activity
- Contribute to vendor oversight activities/interactions from a scientific/medical safety perspective
- Contribute to the creation and maintenance of Reference Safety Information, and the safety sections of Investigator Brochures for all investigational products
- Participate in inspection readiness activities and preparation as needed
- Stay current with international pharmacovigilance requirements and guidelines (focus on FDA and EMA)
- Maintain knowledge in disease and therapeutic area aligned to compound responsibilities
- May have direct report(s) and responsible for oversight and performance of their activities
- Foster an environment of collaboration, team building, and continuous improvement. Team-focused and comfortable in cross-functional settings
- Other functionality and assignments as mandated by business need
Required Experience
BASIC QUALIFICATIONS:
- Bachelor’s Degree in Medicine, Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree
- Minimum 8 years relevant medical, scientific/clinical, or pharmaceutical experience
OR
- Master’s or Doctorate level Degree Medicine, Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree
- Minimum 4 years relevant medical, scientific/clinical, or pharmaceutical experience
No Relocation Offered for this role
PREFERRED QUALIFICATIONS:
- 2 years of experience in safety science role.
- Competent knowledge of good pharmacovigilance practices. Competent knowledge of US and EU pharmacovigilance regulatory requirements.
- Utilizes professional concepts, regulatory knowledge, personal experience/training and the application of company policies and procedures to resolve a variety of issues.
- Knowledge and experience with safety signal detection and management, safety surveillance, labeling analyses, and ad hoc safety analyses
- Experience in the review of relevant safety information from all sources and analysis of safety data
- Experience with development, authorship, and review of aggregate reports (i.e., PSUR, DSUR, IND annual, NDA annual, etc.), Risk Management Plans, and Risk Evaluation and Mitigation Strategies desirable
- Knowledge of global clinical and post-marketing safety regulations, guidance documents, and reporting processes
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.