Regional Pharmacovigilance Associate Specialist – LATAM Project

Job DescriptionProvide operational support to regional pharmacovigilance activities in LATAM, ensuring continuity, regulatory compliance, and process efficiency following recent regional organizational changes.This role combines operational execution (case follow-up, literature review, and mailbox management) with a project component focused on process optimization and efficiency improvements.Key Responsibilities1. Case Management and Follow-upPerform follow-up activities for Individual Case Safety Reports (ICSRs)Contact healthcare professionals and patients to obtain additional informationEnsure timely and complete documentation according to global PV procedures and LATAM HA requirements2. LATAM PV Mailbox ManagementPerform daily review of the LATAM PV mailboxClassify and distribute incoming communications and casesTrack and follow up on communications with countries and stakeholders3. Literature Monitoring and ReviewPerform initial assessment of scientific literature relevant to pharmacovigilanceIdentify potential safety cases from literature4. Support to Regulatory Reporting (as needed)Support submission of safety cases to Health Authorities across LATAMCoordinate with local PV teams when applicableEnsure compliance with regulatory timelines5. Process Optimization (Project Component)Identify opportunities to improve efficiency in regional PV processesSupport development and implementation of improvements (e.g., templates, trackers, automation)Document optimized workflows and best practicesRequirements:Bachelor Health and related.Fluent EnglishPV knowledge (deseable)Required Skills: Budget Development, Case Management, Change Management, Clinical Supply Chain Management, Clinical Trial Management, Data Analysis, Digital Marketing, Document Workflow, Drug Safety Surveillance, Feasibility Studies, Literature Reviews, Manufacturing Compliance, Office Tools, Operational Execution, Operations Coordination, Pharmacovigilance, Process Optimization, Project Management, Project Management Tools, Project Planning, Regulatory Compliance, Regulatory Reporting, Risk Management, Subcontract Management, Technical Quality AssurancePreferred Skills: Current Employees apply HERECurrent Contingent Workers apply HERESearch Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Project Temps (Fixed Term)Relocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:HybridShift:Valid Driving License:Hazardous Material(s):Job Posting End Date:06/7/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.