Assoc Mgr, Safety Operations (with Portuguese Advanced)

IQVIA Argentina; Teletrabalho; BRL 20.000 - 80.000; Tempo integral

Resumo da oferta

A leading healthcare intelligence firm is seeking an Associate Manager for the Safety Operations Team in São Paulo. The role involves overseeing local pharmacovigilance activities, ensuring compliance, and managing safety operations. Candidates should have at least 5 years of experience in pharmacovigilance and advanced proficiency in English and Portuguese. This position is 100% home-based, offering flexibility and the opportunity to make an impact in patient outcomes.

Qualificações

• 5+ years of relevant experience in pharmacovigilance.
• 3+ years of specific pharmacovigilance experience.
• Advanced proficiency in English and Portuguese (C1/2).

Responsabilidades

• Oversee safety-related operations and communication.
• Ensure ICSR surveillance and reporting.
• Manage mailbox screening and case intake.

Conhecimentos

Pharmacovigilance regulations knowledge

Written and verbal communication

Organizational skills

Time management skills

Teamwork

Data management systems proficiency

Formação académica

Bachelor's degree in Life Sciences

Ferramentas

Argus

Apex

Descrição da oferta de emprego

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.

Work Arrangement

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 at iqvia.jobs