Ardea Biosciences, a wholly owned subsidiary of AstraZeneca, is headquartered in San Diego, CA. We are a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases.
We are searching for a Pharmacovigilance Executive Medical Director to join the team.
Lead and manage the Pharmacovigilance function in the Regulatory Affairs department. Responsible for safety and risk management strategy for company products including signal detection, risk evaluation and mitigation strategy (REMS) and risk management plans (RMPs). Oversight of activities associated with independent data monitoring committees (DMC) and adjudication committees.
Primary Duties and Responsibilities
·Chair the Safety Council and attend Safety Management Team (SaMT) team meetings.
· Author safety summaries for submissions to both US and international regulatory agencies such as INDs, Development Safety Update Report (DSURs), and meeting information packages.
· Manage external pharmacovigilance vendor responsible for case processing.
· Work with parent company and their affiliates for alignment of safety processes, where applicable, and for transfer of cases for post-marketing reporting.
· Work with the chairs of independent DMCs and adjudication committees and with the external vendors for all products to ensure that charters are developed and followed.
· Author safety sections of labeling documents such as the development core data sheet, US Package Insert and EU Summary of Product Characteristics.
· Work with medical science director for each product to evaluate the impact of potential safety findings during clinical trials on the project risk/benefit framework.
· Review pharmacoepidemiology study protocols and reports to be conducted during clinical development.
· Assist with planning and review of analyses to be included in high level safety summaries for marketing applications.
· Back up for medical review of SAE cases including coding, narrative, site queries and assessment of reportability (seriousness, causality and expectedness assessments).
· Back up medical review and approval of final Serious Unexpected Suspected Adverse Reaction (SUSAR) for submission to the Health Authorities and Marketing Authorization Holders (MAHs).
· Manage the pharmacovigilance staff.
· Other duties as assigned.