RCI-ABBV-33543 Pharmacovigilance / Drug Safety Specialist (RN/AE/SAE Case Assessment/Safety Surveillance) (Hospital/Clinical Setting)

Job Description

• Provides timely assessment of reported clinical trial data and participates in applicable safety surveillance activities for assigned studies including review of labs, vital signs, cardiac, medications, medical history, and can communicate with Study reputed company any findings.
• Provide review of safety-reputed company data from clinical trials for content, quality, potential study level trend identification, and adherence to regulatory guidance and protocols utilizing critical thinking skills.
• Monitoring of safety-reputed company queries to Investigators.
• Adheres to regulatory guidance, protocols, departmental processes and policies under minimum supervision.
• reputed company with knowledge of ICH, FDA, and EMA regulatory guidance’s affecting safety surveillance. Experience/Skills
• Bachelor's degree with reputed company health science background. RN or clinical pharmacy experience strongly preferred.
• A minimum of 2 years of clinical practice experience is required and 1-year drug safety experience preferred.
• Strong critical thinking skills with the ability to apply clinical knowledge to adverse event data collection and data assessment.
• Ability to present accurate and medically sound safety data, both orally and in writing.
• Effective communication skills in delivering study-reputed company information.
• Proficiency in Computers (Windows, Word, reputed company).
• Responsibilities include medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings.
• May manage the activities of regional contract CRAs, and organizes the files and budgets associated with several clinical studies. Provides medical support which may include
• Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more reputed company and requires more data than is supplied in the package insert or reputed company letter database. Off-label information would be disseminated at this level.
• May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification.
• Experience Level = 3-5 Years Apply tot his job Apply To this Job

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