senior ui

PawCo Foods; Málaga; Presencial; EUR 50.000 - 75.000; Jornada completa

Descripción de la vacante

A leading company in the pharmaceutical industry seeks a Risk Management Manager to oversee risk management activities and ensure compliance within the Vigilance system. The ideal candidate will have extensive experience in pharmacovigilance and strong analytical and communication skills.

Formación

• Minimum 4 years experience in the pharmaceutical industry, especially pharmacovigilance.
• Experience in project management required.
• Ability to interact effectively at all levels.

Responsabilidades

• Oversee and trend Quality Issues and Quality Events.
• Lead strategic projects related to Risk Management of the Vigilance System.
• Act as SME during audits and implement corrective actions.

Conocimientos

Negotiation

Presentation

Communication

Analytical skills

Mentoring

Educación

PharmD or 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 the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling. Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing.

About the Role

The Risk Management Manager leads activities and initiatives designed to identify and categorize risks that potentially impact the Vigilance system and the broader PS&PV organization as well as the preparation of action plans for PS&PV leadership endorsement. Ensure oversight of management of Patient Safety Quality Issues and Quality Events in AQWA / 1QEM.

Your key responsibilities, but not limited to :

• Oversee and trend areas such as receipt of Quality Issues and Quality Events, entry into AQWA / 1QEM, timely investigations, implementation of CAPAs, and effectiveness checks.
• Drive development of insights and mitigation plans for improvement opportunities.
• Lead strategic projects related to Risk Management of the Vigilance System.
• Prepare and maintain guidance documents and training materials for Patient Safety associates.
• Monitor compliance and develop strategies for addressing deficiencies.
• Collaborate across functions to produce metrics and trend analyses to identify risks.
• Establish and meet joint accountabilities with global functions and third parties.
• Develop and maintain procedural documents and oversee compliance with regulations.
• Act as SME during audits, lead responses, and implement corrective actions.
• Prepare reports on risk assessments and escalate key findings.
• Support management of the Operational Metrics & Risk Committee as Secretary.

Minimum Qualifications :

• Minimum 4 years of experience in the pharmaceutical industry, especially pharmacovigilance.
• Experience in project management and leading work groups.
• Ability to interact effectively at all levels.
• Strong negotiation, presentation, and communication skills.
• Excellent analytical skills.
• Ability to mentor and coach.

Educational Background :

PharmD, MSc in Life Sciences or equivalent.

Commitment to Diversity & Inclusion :

Novartis is committed to creating an inclusive work environment and diverse teams that reflect the patients and communities we serve.

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