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The Estee Lauder Companies Postmarket Surveillance -Medical Reviewer, Safety in Melville, New York
Postmarket Surveillance -Medical Reviewer, Safety
Brand: Estée Lauder Companies
The primary function of this position is to perform independent review of safety related data from individual safety case reports for content, quality, adherence to regulatory requirements and guidance, and protocols by collecting, analyzing, triaging and assessing adverse events, as this position impacts product approval, safety signal identification, and consumer safety.
Key Roles & Responsibilities:
Decision Making (70%) - With experience in health sciences, the candidate will need to conduct timely medical review of Individual Case Safety Report (ICSR) from post market spontaneous adverse event reporting and literature. Review all AEs and determine whether the events are accurately captured to reflect what occurred medically with the consumer and confirm events are correctly coded with MedDRA. Interact with data intake and entry group(s) to ensure complete and quality output and provide guidance on follow-up as needed. Evaluate medical content and case completeness, create case narratives, and determine the event expectedness and company causality assessment. Ability to accurately and medically present case data, both orally and in writing. Ability to identify, prioritize and monitor problems through resolution. Consistently exercise good judgment within policies and regulations. Experience with US and global PV/CV regulations is desirable. Workload responsibilities are primarily individual case related and include identifying potential safety signals at single case level.
Must possess the ability to work efficiently in a fast-paced environment, and deal effectively with changing priorities.
Detail oriented and multi-tasking ability to meet re
Problem Solving (10%) - Candidate will need to identify and trouble shoot safety database problems and proper escalation to manager.
Independence of Action and Accountability (10%) - Candidate will assist in the development of SOPs and/or updates of SOPs, Work Instructions, forms or other internal documents as needed for consistency and accuracy of case coding.
Leadership (10%) - conduct training to new team members in medical review and conduct cross training for case coding team.
Bachelor's degree with related health science background is required. RN or clinical pharmacology experience strongly preferred.
4 years experience with a minimum of 3 year drug safety/pharma experience or equivalent combination of education, training and experience (medical coding/terminology within a pharmaceutical organization). Proficiency in Computers (Windows, Word, Excel) and in specific databases (e.g. Oracle/Argus, safety databases). Proficiency in medical adverse event coding (MedDra).
Ability to critically evaluate medical data. Proficient investigative/inquiry skills and knowledge of the etiology of disease. Medical case review/assessment experience required.
Job: Research & Development
Primary Location: Americas-US-NY-Melville
Job Type: Standard
Shift: 1st (Day) Shift
Travel: Yes, 5 % of the Time
Job Number: 1912480
We are an equal opportunity employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply. It is Company's policy not to discriminate against any employee or applicant for employment on the basis of race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. The Company will endeavor to provide a reasonable accommodation consistent with the law to otherwise qualified employees and prospective employees with a disability and to employees and prospective employees with needs related to their religious observance or practices. Should you wish to apply for this position or any other position with the Company and you believe you require assistance to complete an application or participate in an interview, please contact USApplicantAccommodations@Estee.com