Medical Director/Associate Medical Director; Neurology (Ezeiza)

Work ScheduleStandard Office Hours (40 per week)Environmental ConditionsOfficeJob DescriptionAs part of the Thermo Fisher Scientific team you will discover meaningful work that makes a positive impact on a integral scale.
Our detailed, goal‐oriented pharmacovigilance colleagues manage the safety profile of new drugs in clinical trials, oversee case‐processing activities through all phases of development and perform regulatory reporting and medical monitoring.ResponsibilitiesProvide medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed.Attend and present at investigator and sponsor meetings, provide medical consultation to clients, investigators and project team members, and support business development activities.Provide medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports (e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR).
Ensure tasks delegated to PVG are properly executed.Adhere to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues.Adhere to client SOPs/directives and project specific WPDs for assigned projects.Adhere to PPD's corporate policies and SOPs/WPDs.Provide medical consultation to team members and answer all study‐related medical questions.Communicate clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.Provide therapeutic training and protocol training on assigned studies, as requested.Assist in writing and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete.Monitor all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un‐blinding requests) of clinical studies.Discuss all medical concerns with principal investigators and clients (e.g., interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study.Provide medical review of adverse events of special interest, serious adverse events, and clinical outcomes events reported by study sites.Perform data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns.Manage signal detection activities, scientifically review aggregate reports, contribute to label updates, support dossier maintenance and risk management activities.Medically review adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as contracted.QualificationsMD or equivalent required.Active medical licensure preferred but not required.Candidates should have clinical experience in neurology and formal training in neurology (e.g. residency and/or fellowship), along with patient treatment experience comparable to 2 years.For Medical Director level: MD or equivalent required; active medical licensure preferred but not required.
Candidates should have a combination of clinical experience and industry experience as follows:Clinical experience in neurology and formal training in neurology (e.g. residency and/or fellowship), along with patient treatment experience comparable to 2 years and one of the following:Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator comparable to 1–2 years in the industry; or direct experience in safety/pharmacovigilance comparable to 2 years.Experience preference towards individuals with clinical development/medical monitoring.In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.Job leveling at Associate Medical Director or Medical Director will be determined during the consideration process, inclusive of education, experience, therapeutic area(s), and interview results.Knowledge, Skills and AbilitiesTherapeutic expertise across one or more medical specialty or sub‐specialties.Strong decision‐making, problem‐solving, organizational skills and analytical skills.Excellent oral and written communication skills.Working knowledge of relevant safety databases (e.g. Medra).
Flexibility to travel domestically and internationally.Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information.Proficiency in basic computer applications.Fluent in spoken and written English.Excellent interpersonal, influencing and team building skills.Understanding guidelines (FDA, ICH, EMA and GCP).
Working knowledge of biostatistics, data management, and clinical operations procedures.Ability to act as a mentor/trainer to other staff.Physical Requirements / Work EnvironmentWork is performed in an office environment with exposure to electrical office equipment.Occasional drives to site locations with occasional travel both domestic and international.Frequently stationary for 6–8 hours per day.Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.Frequent mobility required.Occasional crouching, stooping, bending and twisting of upper body and neck.Light to moderate lifting and carrying of objects including luggage and laptop computer with a maximum lift of ***** lbs.Ability to access and use a variety of computer software developed both in‐house and off‐the‐shelf.Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.Frequently interacts with others to obtain or relate information to diverse groups.Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.Requires multiple periods of intense concentration.Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.Ability to perform under stress.Ability to multi‐task.Regular and consistent attendance.BenefitsWe offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.EEO StatementThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Job ID#J-****-Ljbffr
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