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Drug Safety Specialist, GPIO

Parexel International Corporation

Romania - Any Region - Home Based

The Drug Safety Specialist will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).

Key Accountabilities: Collection of safety requirements Data entry and maintenance of country specific requirements in Parexel’s Safety Services repository Receipt and triage of requests for updates to country requirements Communicate country-specific regulatory updates to project teams as required Maintain updated network list of Named Safety Contacts/LQPPV Work directly with relevant stakeholders on standalone safety intelligence projects Assist Medical Directors/Safety Physicians as needed in project-related tasks Arrange and attend project meetings as needed Provide the tasks specific training to new team members Mentor new team members Qualifications.Skills: Sound knowledge of drug safety and the drug development process Knowledge of and ability to interpret and apply global safety regulations Experience in data analysis and evaluation of safety data Good presentation skills Analytical and problem solving skills Clear understanding of the regulatory submission process Proficient in database/literature searches Excellent interpersonal skills Excellent verbal / written communication skills Excellent organizational and prioritization skills Ability to work collaboratively and effectively in a team environment Client focused approach to work Experience with computer applications including database management and pharmacovigilance systems Knowledge and Experience: Drug safety knowledge and experience Education: Degree in Pharmacy, Nursing, Life Science, or other health-related field , or equivalent qualification/work experience Associates/diploma degree in any of the above with appropriate work experience

Job posted: 2021-04-08

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