Assoc Mgr, Safety Operations

Há 3 dias

São Paulo, Brasil IQVIA Tempo inteiro

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:
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

  • Content Safety Operations

    4 semanas atrás

    São Paulo, Brasil Meituan Tempo inteiro

    Basic InformationDepartment: Core Local Commerce - Basic R&D PlatformJob Category: Strategic Product ManagerCity: BrazilLevel: L7Job Responsibilities1.Be responsible for the content safety risk management work of Meituan food delivery in Brazil; 2.Build a comprehensiveContent safety solution based on local policy/regulatory requirements and business needs...

  • Safety Operations Manager

    2 semanas atrás

    São Paulo, Brasil DiDi Global Tempo inteiro

    Company Overview:If you see technology as a way to smooth your path in life, our team does too: Your Path, Our Journey.We believe in technology that connects talented people who embrace diversity to create and share paths we don't even know about (yet!). We work to generate value not only for our users but, above all, for the communities we serve and for...

  • Crisis Incident Specialist

    1 semana atrás

    São Paulo, Brasil Keeta Tempo inteiro

    We’re Hiring — Crisis Incident Specialist | Incident Safety Operations Location: Sao Paulo, Sao Paulo Work Model: On-site with flexibility to respond outside normal business hours when required Languages: English & Portuguese fluency required About the Role We are seeking Crisis Incident Specialists to join our Incident Safety Operations team. You will...

  • Crisis Incident Specialist

    3 semanas atrás

    São Paulo, Brasil Keeta Tempo inteiro

    We’re Hiring — Crisis Incident Specialist | Incident Safety OperationsLocation: Sao Paulo, Sao PauloWork Model: On-site with flexibility to respond outside normal business hours when requiredLanguages: English & Portuguese fluency requiredAbout the RoleWe are seeking Crisis Incident Specialists to join our Incident Safety Operations

  • Crisis Incident Specialist

    2 semanas atrás

    São Paulo, Brasil Keeta Tempo inteiro

    We’re Hiring — Crisis Incident Specialist | Incident Safety Operations Location:Sao Paulo, Sao Paulo Work Model:On-site with flexibility to respond outside normal business hours when required Languages:English & Portuguese fluency requiredAbout the RoleWe are seeking Crisis Incident Specialists to join our Incident Safety Operations team. You will act as...

  • Crisis Incident Specialist

    2 semanas atrás

    São Paulo, Brasil Keeta Tempo inteiro

    We’re Hiring — Crisis Incident Specialist | Incident Safety Operations Location:Sao Paulo, Sao Paulo Work Model:On-site with flexibility to respond outside normal business hours when required Languages:English & Portuguese fluency requiredAbout the RoleWe are seeking Crisis Incident Specialists to join our Incident Safety Operations team. You will act as...

  • Crisis Incident Specialist

    2 semanas atrás

    São Paulo, Brasil Keeta Tempo inteiro

    We’re Hiring — Crisis Incident Specialist | Incident Safety Operations Location: Sao Paulo, Sao Paulo Work Model: On-site with flexibility to respond outside normal business hours when required Languages: English & Portuguese fluency required About the Role We are seeking Crisis Incident Specialists to join our Incident Safety Operations team. You...

  • Crisis Incident Specialist

    2 semanas atrás

    São Paulo, Brasil Keeta Tempo inteiro

    We’re Hiring — Crisis Incident Specialist | Incident Safety Operations Location: Sao Paulo, Sao Paulo Work Model: On-site with flexibility to respond outside normal business hours when required Languages: English & Portuguese fluency required About the Role We are seeking Crisis Incident Specialists to join our Incident Safety Operations team. You...

  • Crisis Incident Specialist

    2 semanas atrás

    São Paulo, Brasil Keeta Tempo inteiro

    We're Hiring — Crisis Incident Specialist | Incident Safety Operations Location: Sao Paulo, Sao Paulo Work Model: On-site with flexibility to respond outside normal business hours when required Languages: English & Portuguese fluency required About the Role We are seeking Crisis Incident Specialists to join our Incident Safety Operations team. You will act...

  • Crisis Incident Specialist

    1 semana atrás

    São Paulo, Brasil Keeta Tempo inteiro

    We’re Hiring — Crisis Incident Specialist | Incident Safety OperationsLocation:Sao Paulo, Sao Paulo Work Model:On-site with flexibility to respond outside normal business hours when required Languages:English & Portuguese fluency requiredAbout the RoleWe are seeking Crisis Incident Specialists to join our Incident Safety Operations team. You will act as...