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**Education and Experience**:- 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).
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**:- Therapeutic expertise across one or more medical specialty or sub-specialties (one being Oncology or Hemato-Oncology)- Excellent interpersonal skills, influencing and team building skills- Understanding of 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 within pharmacovigilance- Strong, well supported decision-making, problem solving, organizational skills and analytical skills- Excellent oral and written communication skills- Working knowledge of relevant safety databases (e.G.
MedDRA)- Flexibility to travel domestically and internationally for short periods- Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information- Fluent in spoken and written English**Working Conditions and Environment**:- Work is remote but occasionally will be performed in an office environment with exposure to electrical office equipment- Occasional travel both domestic and international**Physical Requirements**:- 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, short term mobility required- Occasional crouching, stooping, bending and twisting of upper body and neck- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 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**General Support**:- Ensures tasks delegated to pharmacovigilance are properly executed