Patient Safety Case Intake Advisor - Global Business Services (English & Canadian French)

AstraZeneca; Guadalajara; Híbrido; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

A leading biopharmaceutical company seeks a Patient Safety Case Intake Advisor in Guadalajara. The role involves managing individual case safety reports, ensuring compliance with regulations, and providing expertise in pharmacovigilance. Candidates must be proficient in English and Canadian French, with a degree in relevant fields.

Formación

• Degree or equivalent experience in Pharmacy, Medical, or Science.
• Knowledge of pharmacovigilance and health authority regulations.
• Strong communication and problem-solving skills.

Responsabilidades

• Handle intake, processing, and reporting of individual case safety reports.
• Support pharmacovigilance activities and ensure regulatory compliance.
• Engage in patient safety expertise and mentorship.

Conocimientos

Attention to detail

Problem-solving

Excellent communication

Collaborative approach

Educación

Degree in Pharmacy, Medical, or Science

Descripción del empleo

Patient Safety Case Intake Advisor - Global Business Services (English & Canadian French)

Positions are open to Mexican Citizens and official residents of Mexico.
Location: Guadalajara (hybrid)
Strong English and Canadian French communication skills required

Must Submit Resume in English

About AstraZeneca

AstraZeneca functions as a global biopharmaceutical corporation dedicated to discovering, developing, and commercializing prescription medicines for some of the most critical diseases globally. We're more than just one of the world's leading pharmaceutical companies.

At AstraZeneca, we're proud of our outstanding workplace culture that encourages innovation and collaboration. Employees are empowered to express different perspectives and are valued, energized, and rewarded for their ideas and creativity.

About The Role

The Case Intake Advisor handles the intake, processing, and reporting of individual case safety reports (ICSRs) at the local level. This role supports local Marketing Companies to ensure compliance with AstraZeneca and national regulatory requirements, acting as the primary liaison between those companies and GBS-PS.

The Local Case Intake Advisor must be proficient in English and Canadian French.

Core responsibilities include:

1. Supporting ICSR processing, including adverse event reporting from clinical and post-marketed sources.
2. Supporting interactions with health authorities regarding ICSR queries.
3. Contributing to the operational implementation of the Quality Management System, including procedural document management, training, handling quality incidents, and audit readiness.
4. Engaging in PV aspects related to Data Collection Programmes, Digital and Social Media activities, and collaborations with external parties.
5. Providing Patient Safety expertise and mentorship within the local Marketing company for issue management, risk management, and safety data analysis.
6. Participating in local Marketing Company projects.
7. Ensuring PV conduct and document submission align with MC requirements and GVP.

Additionally, the role involves:

• Establishing effective collaboration across functions to meet patient safety requirements.
• Conducting activities consistent with AstraZeneca's values and policies.

Accountabilities

• Supporting pharmacovigilance activities, including data collection, reporting, and tracking of AEs and ICSRs.
• Reviewing and processing safety data, distributing reports, and ensuring regulatory compliance.
• Identifying Product Quality and Security complaints.
• Responding to regulatory queries and implementing corrective actions.
• Ensuring data reconciliation and periodic screening of regulatory databases.
• Performing literature searches and manual follow-up activities as required.
• Maintaining proper filing and archiving of patient safety documents.

Requirements

• Degree or equivalent experience in Pharmacy, Medical, or Science.
• Knowledge of pharmacovigilance and health authority regulations.
• Collaborative approach, problem-solving skills, attention to detail, and excellent communication skills.

Desirable

• Influencing, conflict resolution, medical knowledge in therapeutic areas, project management, and audit experience.

Why AstraZeneca?

We seize opportunities for change, pioneering innovative methods and fostering diverse teams. Join us to be part of building a new kind of biopharmaceutical organization.

Next Steps

If you're interested, we look forward to hearing from you.

Learn More

Follow AstraZeneca on LinkedIn, Facebook, and Instagram.

Equal Opportunity Employer

AstraZeneca is committed to diversity and inclusion, considering all qualified applicants without discrimination.

Work Location Flexibility

In-person work is expected a minimum of three days per week, with flexibility considered.

Important Dates

Posted: 21-May-2025

Closing: 08-Jun-2025

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