Safety & PV Specialist (case processing) Hybrid Mexico

hace 2 días


Mexico City Syneos Health, Inc. A tiempo completo

Safety & PV Specialist (case processing) Hybrid MexicoUpdated: October 4, 2025Location: MEX-Mexico City-HybridJob Summary:Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.Job Responsibilities:Perform comprehensive medical review and clarification of trial-related Adverse Events, ensuring accurate documentation and timely reporting to regulatory authoritiesProvide detailed aggregate reviews of safety information, identifying potential safety signals and trends that may impact the clinical trial outcomesServe as an internal consultant to pharmacovigilance case processing teams, offering expert guidance on complex safety issues and ensuring compliance with regulatory requirementsContribute to the detection of safety signals and trends through rigorous analysis of safety data, utilizing advanced methodologies and toolsConduct thorough risk management assessments, evaluating the potential risks associated with clinical trials and recommending appropriate mitigation strategiesProvide proactive safety support to clinical development teams, collaborating closely to enhance the overall quality and safety of clinical trialsParticipate in all aspects of the medical safety team's involvement in assigned trials, including protocol development, safety monitoring, and reportingEnsure accurate and timely reporting of safety information, maintaining high standards of data integrity and compliance with regulatory guidelinesEnhance the overall quality and safety of clinical trials by implementing best practices and continuous improvement initiativesQualifications:Bachelor's degree in a relevant field (e.g., Pharmacy, Medicine, Life Sciences)Minimum of 1-2 years of experience in pharmacovigilance or related fieldStrong understanding of clinical trial processes and safety regulationsExcellent analytical and problem-solving skillsEffective communication and interpersonal skillsCertifications:Certification in Pharmacovigilance or Drug Safety (preferred)Relevant professional certifications (e.g., PMP, Six Sigma) (optional)Necessary Skills:Proficiency in medical review and safety signal detectionAbility to manage and interpret complex safety dataStrong attention to detail and accuracyAbility to work independently and as part of a teamProficiency in using pharmacovigilance databases and softwareSyneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: jobs@syneoshealth.com One of our staff members will work with you to provide alternate means to submit your application. #J-18808-Ljbffr



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