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Job DescriptionAs part of the Thermo Fisher Scientific team you will discover meaningful work that makes a positive impact on a general 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, GCP, 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), periodic safety reports (PBRER, PSUR, DSUR), and other client deliverables (labeling reconciliation documents, CTD modules, REMS, RMP, CSR).
Ensure tasks delegated to PVG are properly executed; adhere to applicable regulations, ICH guidelines, client SOPs, project‐specific WPDs, and PPD corporate policies; provide medical consultation; communicate clearly with associates and clients; provide therapeutic and protocol training as requested; assist in writing and/or reviewing CSR, IND/NDA reports, ICSR, signal‐detection reports, periodic reports, RMP, REMS, CTD modules, etc.Monitor all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, un‐blinding requests).
Discuss medical concerns with principal investigators and clients; provide medical review of adverse events of special interest, serious adverse events, and clinical outcome events; perform data review as specified in the client contract and data validation manual.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.QualificationsMD or equivalent required; active medical licensure preferred but not required.Clinical experience in Neurology with formal training (residency and/or fellowship) and patient treatment experience of at least two years.For Medical Director level: a combination of clinical experience and industry experience – suitable clinical trial experience in a CRO, pharmaceutical company, or as a principal investigator (1–2years) or direct experience in safety/Pharmacovigilance (2years).
Preference for experience in clinical development/medical monitoring.Education, training, or experience equivalency may be considered.Key AttributesTherapeutic expertise across one or more medical specialties.Strong decision‐making, problem‐solving, organizational, and analytical skills.Excellent oral and written communication; proficiency in basic computer applications.Working knowledge of safety databases (e.g., Medra) and biostatistics, data management, and clinical operations procedures; ability to act as a mentor/trainer.Fluent in spoken and written English; strong interpersonal, influencing, and team‐building skills.Understanding of FDA, ICH, EMA, and GCP guidelines; flexibility to travel domestically and internationally.Physical Requirements / Work EnvironmentWork is performed in an office environment with exposure to electrical office equipment.
Occasional drives to site locations with domestic and international travel.
Frequently stationary for 6–8hours per day.
Repetitive hand movements, occasional stooping, bending, twisting of upper body, and modest lifting up to a maximum weight of ****lbs.
Ability to focus on tasks, multi‐task, perform under stress, and work independently.BenefitsCompetitive 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.
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Postúlate en Kit Empleo: kitempleo.com.ar/empleo/qk6i2

📌 Medical Director/Associate Medical Director; Neurology (San Carlos De Bariloche)
🏢 ThermoFisher Scientific
📍 San Carlos de Bariloche