The Drug Safety Associate is responsible for interpreting relevant federal regulations in the area of drug safety and overall pharmacovigilance (PV) related to the company’s regulated drug products, and establishing and managing PV systems and programs compliant with U.S. FDA, ICH and other applicable regulations.
- Evaluate existing PV systems and programs, and formulate, propose and directly implement continuous improvement plans.
- Identify appropriate tools and systems platforms required to manage a robust PV program.
- Assist in the negotiation of contracts with service providers.
- Assist in the preparation of budgets covering PV activities, including forecasts of payments to vendors
- Assist in the management of pharmacovigilance systems vendors, including the development and implementation of processes, systems and performance measurement mechanisms in support of PV vendor management
- Work with vendors and clinical study sites to develop and implement corrective and preventative action plans to address variances and deviations in their PV activities
- Remain up-to-date on U.S., ICH and other regulatory requirements particularly related to PV.
- Survey relevant publications and other resources to ensure best PV practices.
- Produce periodic drug safety reports as required by relevant regulatory agencies.
- Manage cross-reporting of adverse events to all clinical studies utilizing the company’s drug products
- Provide timely communications to senior management related to risks associated with the use of the company’s drug products
- Bachelor level degree or higher in biological or physical sciences is required.
- At least two (2) years of experience in the bio/pharmaceutical industry, CRO industry, or in a clinical trials unit of an academic medical center which included at least 1 year of drug safety / pharmacovigilance experience is required.
- Background in FDA drug Regulatory Affairs is highly desirable.
- Experience with electronic submissions in the eCTD format is preferred.
- Scientific / technical / clinical background with an emphasis on skills and know-how related to the evaluation, compilation and reporting of clinical and other safety data is preferred.
- Requires excellent attention to details.
- Requires strong interpersonal and team skills; ability to manage multiple initiatives and projects simultaneously.
- Requires excellent written and oral communication skills; ability to work independently and as a team member; demonstrated strong leadership skills.
- Competence in computer programs such as Microsoft Word, Microsoft Excel, Microsoft PowerPoint and Access is required.
- Experience with relevant safety data management software is strongly preferred.
- Working knowledge of FDA, ICH and other regulations related to PV and safety reporting including relevant ICH Guidance is required.
- A working knowledge of CDISC, and MedRA and WHO coding requirements is required.
Please Note: Due to the high volume of responses, only inquiries from highly qualified candidates can be addressed.
No telephone inquiries or recruiters, please.
Vaccinex, Inc. is an equal opportunity employer.
Please send resume and cover letter via e-mail to firstname.lastname@example.org.