As a Medical Safety Physician
Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports
Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion
Perform triage of cases and determine seriousness and relatedness across products as assigned
Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative.
Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas
Escalate complex case issues on client product(s) to the medical review team of the client as appropriate
Conduct assessment of litigation cases across products as assigned
Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups
Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate
Acquire and maintain knowledge of applicable Global Health Authority regulations
Perform any other drug safety related activities as assigned
Specialized knowledge and skills:
Experience with relevant safety databases and related software applications
Proven experience in customer handling and relationship.
Proven ability to perform task management.
Proven people management skills.
Must have good presentation skills and the ability to give presentations.
Knowledge of the Life Sciences Industry and life cycle of drug.
Relevant product and industry knowledge
strong competence with medical and therapeutic terminology
Understanding of Patient Safety regulatory obligation
Good attention to detail
Ability to deliver within established timelines
Fluency in Spoken and written English and excellent comprehension
Education: MBBS / MD
Experience: 0-2 years of experience
Strong motivational skills and abilities, promoting a team-based approach
Strong interpersonal and communication skills, both verbal and written
Strong organizational and leadership skills
Ability to maintain professional and positive attitude
Travel: 0-50% (can be adjusted)
Lifting: 0-50 lbs. (can be adjusted)
Other: Computer work for long periods of time
THIS JOB DESCRIPTION SHOULD NOT BE DEEMED ALL-INCLUSIVE. ADDITIONAL REQUIREMENTS AND EXPECTATIONS MAY BE ASSIGNED. AT ALL TIMES, EMPLOYEES ARE EXPECTED TO ADHERE TO COMPANY POLICIES AND COMPANY SOPS.
Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.
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