The Manager, Pharmacovigilance (PV) and Drug Safety is responsible, with little direct supervision, for interpreting relevant federal regulations in the area of PV and establishing and managing PV and Drug Safety Surveillance Programs at Vaccinex that are compliant with FDA, ICH and other applicable regulations and guidance.
- Evaluate the existing PV activities currently in place at Vaccinex and at its contractors, and propose and implement solutions to correct any operational gaps.
- As needed, identify appropriate tools such as software systems required to manage a robust PV Program at Vaccinex.
- Assist in the negotiation of contracts with vendors of PV software systems as necessary.
- Prepare budgets covering PV and drug safety activities, including forecasts of payments to vendors and safety assessment committee consultants
- As required, manage the activities of pharmacovigilance systems vendors and safety assessment committee members, including the development and implementation of processes, systems and performance measurement mechanisms in support of these activities
- Work with vendors and clinical study sites to develop and implement procedures for the prompt reporting of serious adverse events, and corrective and preventative action plans to address variances and deviations in their PV activities
- Implement identified programs and tools required for the management of Vaccinex PV and drug safety Programs
- Remain up-to-date on U.S., ICH and other regulatory requirements particularly related to PV and drug safety surveillance programs
- Perform analyses of un-blinded, aggregated adverse event data and evaluate trends by adverse event and system organ class
- Survey relevant publications and other resources for PV data relevant to Vaccinex products; include any relevant data in subsequent adverse event analyses
- Organize and manage the Safety Assessment Committee and its periodic meetings; prepare and present the un-blinded data analyses and other materials necessary for drug safety evaluation by the committee at these meetings
- Produce periodic safety reports as required by relevant regulatory agencies.
- Manage cross-reporting of adverse events to all clinical studies utilizing Vaccinex products
- Provide timely communications to senior management related to the clinical risks associated with the use of Vaccinex products
- Periodically revise the clinical experience and drug safety sections of the Investigator Brochures for Vaccinex products being evaluated clinically
- Provide drug safety summaries and adverse event information for the revision of drug product monographs and target product profiles for Vaccinex products
- Assist as needed in the preparation of other regulatory submissions to FDA and other regulatory agencies
- Prepare Package Insert (PI) prior to commercialization of any Vaccinex product.
- B.S./B.A. degree or higher in biological or physical sciences; degrees in nursing and/or pharmacy would be considered beneficial
- At least eight (8) or more years in the bio/pharmaceutical industry, including at least 7 years progressive experience and responsibility in Pharmacovigilance. Experience with regulatory submissions in the electronic eCTD format is a plus.
- Demonstrated experience in the formation of and management of the activities of a safety assessment committee
- Scientific technical background with an emphasis on skills and know-how related to the evaluation, compilation and reporting of clinical and other safety data.
- Excellent attention to details.
- Strong interpersonal and team skills; ability to manage multiple initiatives and projects simultaneously.
- Excellent written and oral communication skills; ability to work independently and as a team member; demonstrated strong leadership skills.
- Competent in computer programs such as Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Access and especially relevant safety data management software.
- Working knowledge of FDA, ICH and other regulations related to PV and safety reporting including relevant ICH Guidance.
- A working knowledge of CDISC and MedRA and WHO coding requirements is essential.
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.