Assoc Mgr Safety Opns Team

hace 1 día

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

  • Assoc Mgr, Safety Operations

    hace 3 semanas

    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:...

  • Assoc Clin Project Mgr

    hace 2 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    **Job Overview** Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Project Lead is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs,...

  • Assoc Mgr, Patients Solutions

    hace 1 día

    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...

  • Experienced Clinical Safety Coordinator

    hace 2 semanas

    Buenos Aires, Argentina Medpace A tiempo completo

    Clinical Safety Coordinator Our Latin American activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Safety Coordinator to join our team! This position plays a key role in the pharmacovigilance process at Medpace. Working in a team to accomplish tasks and projects that are instrumental to the company’s success. If...

  • Assoc. Product Mgr

    hace 3 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...

  • Safety Operations Specialist

    hace 3 días

    Buenos Aires, Argentina Tidal A tiempo completo

    Safety Operations Specialist Tecpetrol Safety Operations Specialist OpsArmy Regional EHS Specialist: Safety Standards & ImprovementCargillA global agricultural leader is seeking a Regional Health and Safety Specialist III in Buenos Aires. This role involves executing health and safety policies, developing risk management strategies, and... Regional...

  • Sr. Functional Safety Engineer

    hace 1 día

    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...

  • Cps Ar Safety Intern

    hace 2 semanas

    Buenos Aires, Argentina Coca-Cola A tiempo completo

    At The Coca-Cola Company, we build extraordinary brands and experiences that refresh the world and make a difference. At our Coca-Cola Product Supply (CPS) plant in Argentina, we are committed to delivering excellence in every step of our production while ensuring that safety, health, and environmental standards are met to the highest level. **_ What...

  • Experienced Clinical Safety Coordinator

    hace 6 días

    Buenos Aires, Argentina Medpace, Inc. A tiempo completo

    Job Summary: Our Latin American activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Safety Coordinator to join our team! This position plays a key role in the pharmacovigilance process at Medpace. Working in a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an...

  • Remote Associate Manager, Safety Operations

    hace 3 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    A global healthcare solutions provider is seeking an Associate Manager for the Safety Operations Team based in Buenos Aires, Argentina. The role entails leading pharmacovigilance activities to ensure compliance with regulatory requirements, overseeing safety-related operations, and collaborating with stakeholders. Ideal candidates will have a Bachelor's...