Risk Management Manager

Novartis Farmacéutica; Cartagena; Presencial; EUR 50.000 - 80.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical company is seeking a Risk Management Manager to oversee the Vigilance system and ensure compliance with regulations. The role involves managing quality issues, preparing reports, and collaborating with various functions to enhance patient safety. Candidates should have a PharmD or MSc in Life Sciences and at least 4 years of relevant experience.

Formación

• At least 4 years of experience in the pharmaceutical industry, especially pharmacovigilance.
• Experience in project management and leading work groups.
• Ability to mentor and coach team members.

Responsabilidades

• Overseeing and trending Quality Issues and Events.
• Preparing reports for risk assessments and escalating key findings to senior management.
• Serving as a subject matter expert during audits and inspections.

Conocimientos

Interpersonal skills

Negotiation

Presentation

Communication

Analytical skills

Educación

PharmD

MSc in Life Sciences

Descripción del empleo

Monitors and audits the company’s drug, biologics, or medical devices surveillance program, including the intake, evaluation, processing, and follow-up on adverse reports. Participates in resolving legal liabilities and ensuring compliance with government regulations. Ensures accurate receipt, maintenance, and assessment of data against product labeling. Reports events or reactions as required by regulatory agencies, including adverse events data from clinical trials, spontaneous or solicited sources, and periodic reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activities and post-marketing surveillance.

About the Role

The Risk Management Manager leads activities and initiatives to identify and categorize risks impacting the Vigilance system and the broader Pharmacovigilance (PV) organization. They prepare action plans for PV leadership endorsement and oversee management of Patient Safety Quality Issues and Quality Events in AQWA / 1QEM.

Your key responsibilities include:

1. Overseeing and trending areas such as:
2. Receipt of Quality Issues and Quality Events
3. Entry into AQWA / 1QEM
4. Timely completion of investigations
5. Implementation of appropriate CAPAs with supporting evidence
6. Conducting effectiveness checks
7. Timely closure in AQWA / 1QEM
Driving development of insights and mitigation plans to identify and address opportunities for improvement early.
8. Leading and supporting strategic Risk Management projects related to the Novartis Vigilance System.
9. Preparing and maintaining guidance documents and training materials for Patient Safety staff on handling Quality Issues & Events.
10. Monitoring compliance with Quality Issue & Event processes and addressing deficiencies with strategic initiatives.
11. Collaborating with Compliance, Process Excellence, QPPV Office, and other functions to produce metrics and trend analyses for risk identification.
12. Working with global functions and third parties to establish shared responsibilities.
13. Developing and maintaining procedural documents, including ownership of relevant PSMF sections.
14. Reviewing emerging regulations, assessing impacts, and implementing necessary process changes for compliance.
15. Serving as a subject matter expert during audits and inspections, leading responses, and implementing corrective actions.
16. Preparing reports for risk assessments and escalating key findings to senior management.
17. Supporting operational metrics and risk committee management as Secretary, including scheduling, agenda preparation, and follow-up.

Minimum Qualifications:

• At least 4 years of experience in the pharmaceutical industry, especially pharmacovigilance.
• Experience in project management and leading work groups.
• Strong interpersonal skills for working across all levels.
• Excellent negotiation, presentation, and communication skills in an international environment.
• Strong analytical skills.
• Ability to mentor and coach team members.

Educational Background: PharmD, MSc in Life Sciences, or equivalent.

Commitment to Diversity & Inclusion:

Novartis is dedicated to fostering an inclusive, diverse work environment that reflects the communities we serve.