Assoc Mgr, Safety Operations

hace 2 semanas

Xico, México Iqvia Llc A tiempo completo

Job Overview The Assoc Manager, Safety Operations Team is responsible for leading and overseeing all local pharmacovigilance activities, ensuring compliance with regulations and best practices.This includes the implementation, management, and maintenance of the local pharmacovigilance system.**Key Responsibilities:** Oversight of Pharmacovigilance Operations:* Monitor and oversee all safety-related operations and communication activities.* Serve as the primary point of contact for the Sponsor (when applicable).* Ensure efficient and accurate ICSR (Individual Case Safety Report) surveillance, including collection, reporting, and follow-up.* Manage translation processes as needed.* Author local case narratives for regulatory reporting as required by local authorities.Support & Collaboration:* Support local literature searches, reconciliations, and quality assurance activities.* Assist with audit and inspection readiness.* Collaborate effectively with internal and external stakeholders.Mailbox Screening:* Monitor multiple regional/global AE email inboxes in various languages for all Customer Affiliates.* Assess and take action on all received emails.Case Intake:* Create Case Reports into the Global Safety Database.Follow-up Correspondence:* Perform follow-up with ICSR reporters to obtain additional information as per SOPs.Reconciliation:* Conduct reconciliations with internal functions and licensing partners.Compliance Investigations:* Perform compliance investigations for specific cases.**Qualifications:**• Education: Bachelor's degree in Life Sciences• Languages: English and Portuguese advanced • Experience:* Minimum **5 years** of relevant experience.* Minimum **3 years** of specific Pharmacovigilance experience (intake, case processing, regulatory submissions)• Skills:* Strong understanding of global and local pharmacovigilance regulations and guidelines.* Excellent written and verbal communication skills.* **Proficiency in English,** C1/2 (mandatory).Will be evaluated.* **Proficiency in Portuguese**, C1/2 (mandatory).Will be evaluated.* Strong organizational and time management skills.* Ability to work independently and as part of a team.* Proficiency in using electronic data management systems (e.g., Argus, Apex).**Preferred Qualifications:**• Experience working with global safety databases• Experience as people manager with direct reports • 1 year Experience of Adverse Events Case Triage, Processing and Submission.**100% home-based role**IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.Learn more atIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.We create connections that accelerate the development and commercialization of innovative medical treatments.Everything we do is part of a journey to improve patient outcomes and population health worldwide.To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact.No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.Thank you for your interest in growing your career with us.#J-*****-Ljbffr

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