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Medical Director M-SERM
Thermo Fisher Scientific —Desde casa
- Tiempo completo

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Medical Director M-SERM
Thermo Fisher Scientific —Desde casa
Medically reviews adverse events and serious adverse event data from all sources (solicited, spontaneous, literature, etc) as contracted.

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Medical Director M-SERM

Thermo Fisher Scientific -
Desde casa

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Detalles del empleo

Tiempo completo

Descripción completa del empleo

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join us as a Medical Director M-SERM - And lead our efforts in medical safety evaluation and risk management.

What You’ll Do:

Maintain understanding of methods for recording time spent on project and administrative tasks, expense submissions and travel.
Ensure tasks delegated to PV 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 CRG’s corporate policies and SOPs/WPDs.
Provide medical consultation to team members and answer all project/study related medical questions. Communicate clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
Provide safety reporting training on assigned projects/studies, as requested.
Medically reviews adverse events and serious adverse event data from all sources (solicited, spontaneous, literature, etc) as contracted.
Provide medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported in Clinical Trials.
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.

Assist in writing (interpretation of safety data) 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.

Manage signal detection activities, scientifically review periodic safety reports, contributes to label updates, supports dossier maintenance and risk management

activities.

Education and Experience:
MD or equivalent required. History of an active medical license is highly preferred. Candidates should have at least one of the following:

Clinical experience in having direct responsibility for diagnostic and treatment decisions (comparable to 2 years);

Direct experience in medical review and assessment of safety information/Pharmacovigilance (comparable to 3 years).

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.

Knowledge, Skills and Abilities:

Fluent in spoken and written English
General medical knowledge of diagnostic and therapeutic approaches across multiple specialties. Therapeutic expertise across one or more medical specialties or sub-specialties preferred
Strong decision-making, problem solving, organizational skills and analytical skills
Excellent oral and written communication skills
Excellent interpersonal skills
Working knowledge of guidelines (FDA, ICH, EMA and GCP)
Understanding of basic biostatistics, data management, and clinical operations procedures
Excellent organizational skills
Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information
Working knowledge of the drug development process and thorough understanding of guidelines for marketing authorization submissions and international guidelines for conduct of clinical studies
Working knowledge of clinical program and study design, relevant endpoints, safety considerations, and current regulatory and commercial landscape.
Working knowledge of marketed products pharmacovigilance regulations
Working knowledge of Drug Safety Dictionaries (e.g. MedDRA)
Working knowledge of relevant safety databases (e.g. ARGUS, ARISg)
Ability to act as a mentor/trainer to entry level staff within the Pharmacovigilance Department
Flexibility to travel domestically and internationally
Proficiency in basic computer applications
Ability to serve as a group liaison with other CRG groups and clients

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