Assoc Mgr, Safety Operations (with Portuguese Advanced)

IQVIA; Ciudad de México; A distancia; MXN 1,292,000 - 1,662,000; Jornada completa

Descripción de la vacante

A leading global provider of clinical research services is seeking an Assoc Manager for the Safety Operations Team. This role involves overseeing pharmacovigilance operations, ensuring compliance, and managing case reports. The ideal candidate will have a Bachelor's in Life Sciences, 5 years of experience in pharmacovigilance, and proficiency in English and Portuguese. This is a 100% home-based position, offering the chance to contribute to improving patient outcomes.

Formación

• Minimum 5 years of relevant experience.
• Minimum 3 years of specific Pharmacovigilance experience.
• Proficiency in English and Portuguese at C1/2 level.

Responsabilidades

• Monitor and oversee all safety-related operations.
• Ensure efficient ICSR surveillance.
• Manage case reports in the Global Safety Database.
• Conduct compliance investigations.

Conocimientos

Pharmacovigilance regulations

Excellent written and verbal communication skills

Organizational and time management skills

Proficiency in electronic data management systems

Independence and teamwork

Educación

Bachelor's degree in Life Sciences

Herramientas

Argus

Apex

Descripción del empleo

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 in 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

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 https://jobs.iqvia.com