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Energy Service Company
LLC

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Counsel Jobs > Health Care/Attorney/In House/Bridgewater, New Jersey Job in New Jersey > Health Care/Attorney/In House/Bridgewater, New Jersey

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Health Care/Attorney/In House/Bridgewater, New Jersey

Refer job# XQDH57672

ASO Director Duties: To determine the safety profile of assigned registered/marketed products through the medical assessment of adverse reactions and product technical complaints leading to adverse events and the early detection and evaluation of potential safety signals. Providing essential safety expertise for decisions related to study proposals and protocols, regulatory labeling, cross-functional Medical Affairs activities, internal processes, as well as responding to requests from the local Regulatory Authority. Contributes to the development of risk management strategies and risk minimization tactics and related implementation and communication plans for assigned registered/marketed products. Additionally, responsibilities include the adaptation of the Global Risk Management Plan (RMP) to local specificities for products submitted for U.S. approval. Ensures high-quality and timely medical evaluation of ICSR from spontaneous and solicited reporting sources, in compliance with FDA regulations and Corporate policy, in close collaboration with Case Management team. Accurately assesses ICSR report ability for regulatory submission, in accordance with FDA regulations, post-marketing commitments to FDA, and Corporate policy. For aggregate data safety review: Autonomously prepares relevant sections of Periodic Adverse Drug Experience Reports for FDA, demonstrating best practices in safety analysis and in medical/business writing. Proactively identifies and evaluates potential safety signals utilizing state-of-the-art tools, through early active surveillance of aggregate post marketing safety data to ensure accurate and robust product safety information. Autonomously performs ad hoc safety reviews with integration of quantitative and qualitative information based on needs arising from the regulatory/competitive/business environment and effectively communicates that safety analysis to all relevant stakeholders. As Pharmacovigilance Expert: Maintains comprehensive, up-to-date safety knowledge of assigned products through review of global aggregate safety reports (e.g. PSURs) and through review of relevant scientific literature. Contributes to the training and mentoring of Case Management colleagues and Senior Manager-level Affiliate Safety Officers. Collaborates closely with therapeutically-aligned Medical Information Services and Case Management teams to leverage synergies in effecting shared safety objectives. Provides safety expertise during IST proposal review and US protocol development as well as safety oversight of applicable clinical trials. Actively represents safety perspectives in Labeling Working Group meetings to ensure safety topics and risks are adequately addressed. Provides safety expertise for interactions with FDA and other customers regarding ad hoc safety requests and inspections. Determines the safety profile and potential product risks of new and existing products from spontaneous report data as well as medical literature and post-marketing studies of any type in collaboration with relevant corporate departments (e.g. development, medical, Pharmacovigilance). Due diligence activities for products being evaluated for in-licensing or purchase and related safety data exchange agreements. Forecasts resource needs for new products and for expanded indications of existing products, based on marketing projections and sales data. For Risk Management and Communication: Collaborates with Evidence Based Medicine and Medical Units in the development, analysis and interpretation of study data to optimize the effective and safe use of Sanofi products. Collaborates with cross-functional Medical Affairs Core Team to provide strategic input that is compliant and effectively links to the Business Unit needs. Participates in the development and communication of Risk Management strategies, as well as the risk minimization tactics, in support of assigned products. Acquires full knowledge of the safety specifications and context motivating a RMP and REMS; consults appropriate experts and functions to propose local adaptations to a global Pharmacovigilance plan or create a local RMP as needed, in collaboration with US RISC management. Contributes to the writing, coordination, review, approval and maintenance of the local RMP and local REMS. Effectively communicates RMP and REMS to all relevant internal stakeholders. Participates in the preparation of communication documents related to REMS activities to Health Care Providers, Patients, and Risk Management Experts. Responsible for maintaining up-to-date knowledge regarding concerned products, regulatory environment, risk management methods and regulations. Qualifications: Doctorate degree from an accredited college or university (M.D., J.D., PhD, PharmD, or equivalent). 3-5 years Public Health or clinical practice experience. 2-4 years experience in Safety Surveillance, Pharmacovigilance or Drug Safety. 5-8 years of total experience in the pharmaceutical industry, partly in related areas, such as medical affairs, clinical trials management, regulatory affairs or quality assurance.

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