Risk Management Manager (Pharmaceutical Industry)

Job Description Summary

The Risk Management Manager, (Pharmaceutical Industry experience only), leads activities and initiatives designed to identify and categorize risks that potentially impact the vigilance system and the broader Patient Safety & Pharmacovigilance (PS&PV) organization as well as the prepare action plans for PS&PV leadership endorsement.

 

Job Description

LOCATION: London, Dublin, Barcelona or Madrid.
ROLE TYPE: Hybrid Working, #LI-Hybrid

Key responsibilities but not limited to:

• Drive the development of actionable insights and mitigation plans to ensure that any opportunities for improvement are identified and acted upon as early as possible.
• Lead and support strategic projects related to Risk Management of the Novartis Vigilance System.
• Prepare/maintain guidance documents and training material to educate Patient Safety associates on the Quality Issue & Quality Event process.
• Monitor compliance of the Patient Safety organization to Quality Issue & Quality Event handling processes and standards and where deficiencies are identified, develop and implement strategies to address these.
• Collaborate with the Compliance, Process Excellence, QPPV Office and other functions to produce metrics and complete trend analyses designed to identify areas of risk with impact on the Vigilance System and/or PS&PV organization.
• Collaborate with other Global Line Functions across Novartis Divisions and Third Parties to establish and meet joint accountabilities.
• Leading the development and maintenance of respective procedural documents including ownership of relevant PSMF sections and annexes.
• Support the review of emerging worldwide regulations, performing impact assessments, and driving process changes required to ensure ongoing compliance to global regulatory requirements.
• Act as a subject matter expert during audits and inspections, lead the preparation of responses to findings and the development and implementation of corrective and preventative actions.
• Prepare reports and/or presentations to document the outcome of risk assessments for the Process Governance and Risk Mitigation management team and escalate key findings to the Head Risk Management and/or relevant governance or LT board.
• Support with management of the Operational Metrics & Risk Committee as the Secretary; scheduling the meetings, preparing the agenda and track and follow up on actions.
• Support as business representative during mergers and acquisitions.
• Prepare action plans based on the results of risk assessments, coordinating with other groups within PS&PV and cross functionally as required.
• Train and mentor PS&PV associates as well as associates from other line functions as needed on the Quality Issues and Quality Events process as well as risk identification and mitigation strategies.
• Alert the Head of Risk Management to potential compliance issues. Participate and/or join external conferences and networks for respective areas of expertise.

Essential Criteria:

• Experience in the pharmaceutical industry, particularly in pharmacovigilance
• Experience in project management and demonstrated ability to lead work groups
• Knowledge and experience in risk management (e.g. ISO 31000, ISO 14971, ICH Q9).

Desirable criteria:

• Ability to deal and interact with a wide variety of people at all levels.
• Strong organizational skills
• Strong negotiation, presentation and communication skills, and ability to operate effectively in an international environment and across functions
• Excellent analytical skills
• Ability to mentor and coach

• Fluency in English. Knowledge of other languages desirable.

 

Skills Desired

Databases, Employee Training, Pharmacovigilance, Reporting, Safety Science, Waterfall Model