Assoc Mgr Safety Opns Team

hace 20 horas


Buenos Aires, Argentina IQVIA 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:
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**.
- 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

100% home-based role



  • Buenos Aires, Argentina IQVIA A tiempo completo

    Job Overview Manage Safety staff responsible delivering services in Safety Operations under the guidance of senior management. May contribute to Global initiatives. Work in close collaboration with Senior Management and other relevant stakeholders supporting the achievement of local and global deliverables and metrics. Essential Functions - Implement and...


  • Buenos Aires, Argentina IQVIA 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...

  • Safety Officer

    hace 7 días


    Buenos Aires, Argentina Pfizer A tiempo completo

    Organizational Relationship(s) including to whom the position reports (JD Job Title): - Reports to Country Safety Lead or Safety Team Lead or Safety Officer with senior experience (depending on local organization and safety group size) - Position Purpose - Review, analysis, preparation and completion of safety-related reports within scope of the DSU to...


  • Buenos Aires, Argentina IQVIA A tiempo completo

    ob Overview Business and Customer Management Responsible for conducting training of HCPs in hospitals based on the client needs Responsible for achieving qualitative and quantitative targets and objectives of the project Active involvement during the development and co-ordination of project as well as responsibility for implementation in line with project...

  • Assoc. Dir

    hace 2 semanas


    Buenos Aires, Argentina IQVIA A tiempo completo

    This Assoc./ Medical Director role will provide medical, clinical and scientific advisory expertise to all IQVIA divisions as requested. Participate in all aspects of Medical Science involvement on assigned trials. Serve as a medical expert during project delivery life-cycle. Provide therapeutic medical and strategic expertise to business development...

  • Assoc Mgr, Finance

    hace 2 semanas


    Buenos Aires, Argentina IQVIA A tiempo completo

    IQVIA es la compañía líder de ciencia de datos humanos, enfocada en ayudar a nuestros clientes del rubro del cuidado de la salud a encontrar insights incomparables y mejores soluciones para los pacientes. Surgida de la fusión de IMS Health y Quintiles, IQVIA ofrece una amplia gama de soluciones que utilizan el poder de los datos en salud, la experiência...

  • Country Safety Lead

    hace 2 semanas


    Buenos Aires, Argentina MSD A tiempo completo

    Position Purpose Lead, manage and provide strategic direction to the country pharmacovigilance team. Accountable for all strategic PV activities for the country(ies). Serve as point of contact of Pharmacovigilance Business Line for the PCO. Active contribution to the activities relevant to the pharmacovigilance system to ensure monitoring of the safety...

  • Assoc. Product Mgr

    hace 2 días


    Capital Federal, Buenos Aires, Argentina Epson America, Inc A tiempo completo

    **Responsible for**: Analysis, development, and implementation of strategies and marketing programs to achieve product line placement in the market and high sales volume. Collaborates with/Key Customers include: - Sales Management - Sales Administration Management - Operations Management - Costs Area - Service Area - Design Area - Telemarketing...


  • Buenos Aires, Argentina Allegro MicroSystems, LLC A tiempo completo

    The Allegro team is passionate about providing intelligent solutions that move the world toward a safer and more sustainable future. With more than 30 years of experience developing advanced semiconductor technology, innovation with purpose touches every aspect of our business. From customer engagement and employee recognition to technology advancement and...


  • Buenos Aires, Argentina Allegro MicroSystems, LLC A tiempo completo

    As a Sr. Functional Safety Engineer, you will be responsible for the implementation of the ISO-26262 functional safety design process for our next generation sensor products. These products will be part of the complex electronic sensor systems contained in automobiles that are safety critical. The day-to-day duties will include: - Chip Architecture...