Assoc Mgr, Safety Operations

IQVIA Argentina; São Paulo; Teletrabalho; BRL 60.000 - 90.000; Tempo integral

Resumo da oferta

Une entreprise mondiale de recherche clinique recrute un Manager Associé pour diriger les opérations de pharmacovigilance. Ce poste à distance implique la supervision des activités locales conformément aux réglementations en vigueur, nécessitant une expertise confirmée ainsi que des compétences en communication. Le candidat doit avoir un diplôme en sciences de la vie, avec au moins 5 ans d'expérience en pharmacovigilance.

Qualificações

• Minimum 5 ans d'expérience pertinente en pharmacovigilance.
• Expérience en gestion d'équipe et de personnes préférée.
• Compréhension forte des réglementations locales et mondiales.

Responsabilidades

• Surveillance et supervision des opérations de pharmacovigilance.
• Création de rapports de cas dans la base de données de sécurité mondiale.
• Collaboration avec des parties prenantes internes et externes.

Conhecimentos

Communication écrite et verbale

Compétences organisationnelles

Gestion du temps

Capacité à travailler de manière autonome

Compétences en pharmacovigilance

Proficience en anglais

Proficience en portugais

Formação académica

Diplôme de licence en sciences de la vie

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
• Experience:
Minimum 5 years of relevant experience.
Minimum 3 years of Pharmacovigilance experience.
• Skills:
Strong understanding of global and local pharmacovigilance regulations and guidelines.
Excellent written and verbal communication skills.
Proficiency in English (mandatory)
Proficiency in Portuguese (mandatory)
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 at https://jobs.iqvia.com