Medical Director M-SERM

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);

Or

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