Do you enjoy working in small teams, tackling a variety of responsibilities, and making a difference in peoples’ lives? We are a 150 person, $50 million, not-for-profit, integrated biotechnology organization focused on developing safe, effective vaccines to prevent tuberculosis, a major global health threat. We work in partnership with for-profit pharmaceutical companies and biotechs, academic institutions and other non-profit organizations. The Director of Global Safety and Pharmacovigilance position offers the opportunity to oversee and develop Aeras’ Safety and Pharmacovigilance activities. You will provide clinical safety expertise to the Aeras Clinical Development department and will work with a dynamic team of clinical researchers to ensure that clinical trials of cutting-edge TB vaccine candidates are conducted in accordance with current national and internationally-accepted safety standards. You also will organize, lead and supervise data safety monitoring boards responsible for local assessment of clinical trial safety, and will be the Aeras point person responsible for the evaluation of reported safety signals.
If you would enjoy applying your clinical medical judgment in service of the global effort to develop vaccines to prevent tuberculosis, are adaptable to change, would look forward to working within a team environment, and are eager to take on challenges, this may be a good opportunity for you.
The Director of Global Safety and Pharmacovigilance ensures compliance with timely reporting of the adverse events that meet regulatory requirements for the expedited submissions to the applicable Regulatory Agencies. Responsible for safety and pharmacovigilance activities for all Aeras-sponsored investigational products, receipt and processing of serious adverse events from clinical trials, analysis of safety data, and the identification and investigation of potential safety signals. The Director of Global Safety and Pharmacovigilance is responsible for safety evaluation and risk management activities for Aeras clinical trials. This includes leadership and contribution to development of risk management and pharmacovigilance plans.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Ensures compliance and fulfillment of the ICH requirements with respect to the evaluation, reporting, and surveillance of clinical safety information.
• Provides safety expertise to Aeras Clinical Development department, including review of safety data for all clinical trials, design of relevant forms and edit checks as required, and input into and participation in clinical strategy development teams, study working teams, investigator meetings, regulatory submissions, and IND annual updates.
• Responsible for leading the safety medical reviews and safety management for all Aeras clinical studies
• Performs medical review of individual case safety reports for Aeras clinical trials.
• Serves as a medical liaison between external Global Pharmacovigilance team members and Aeras clinical team members for all Aeras clinical trials.
• Reviews and completes SOPs, work practices and guidelines, forms and templates, and other communications related to risk management and product safety.
• Leads SAE reconciliation process at Aeras.
• Participates in review and investigation of possible product quality issues.
• Leads the signaling and data mining activities utilizing internal and external sources of data. Lead and contribute to the development of innovative safety science tools in the assessment and management of risk.
• Accountable for identification, assessment, and communication of potential safety signals at Aeras.
• Preparation of Risk Management Action Plan (RMAPs) for Aeras-sponsored investigational products.
• Serves as a primary coding resource for coding adverse events and concomitant medications in accordance with company coding conventions.
• Reviews coding listings for accuracy and consistency. Assists in the maintenance of coding dictionaries.
• Organizes, leads and supervises activities related to the functioning of safety committees, including but not limited to, preparing reports; reviewing minutes and meeting documents; ensuring completion of action items; and, participating in the discussion of subject safety issues.
• Contributes to internal company safety committees deliberations on safety matters.
• Participate in the production of abstracts for presentation at professional meetings and help to draft scientific manuscripts.
• Review and provide project management for Registry studies, including liaising with sites to obtain all relevant Registry data
• Trainer and mentor for drug safety personnel in the clinical development team.
• Undertakes ongoing performance review, feedback and development of staff.
It is understood that the incumbent will be expected to display some flexibility and, when pertinent, be able to work in other priority areas. Such transient changes in duties will not represent a change in status and will not place an onerous burden on the incumbent.
Safety support personnel
Medical coding personnel
Director Product Safety
• Global drug safety database knowledge, along with proficient knowledge of regulatory roles and regulations, locally as well as globally
• Must possess excellent clinical interpretation skills based on limited information provided along with a profound understanding of medical terminology
• Should possess excellent interpersonal, decision-making, and organizational skills, along with practiced training skills
• Knowledge of Safety policies and procedures, along with FDA and ICH regulations
• Understanding the coding techniques of incoming serious and non-serious adverse events using terminology prescribed by global regulatory authorities. Proficiency with auto-encoding, MedDRA and WHO-DRUG coding dictionaries
• Ability to develop cooperative working relationships with all levels of stafff