Head Safety Strategy, Epidemiology and Strategic Labelling

Head Safety Strategie, Epidemiologie und strategische Kennzeichnung

Job Introduction

Provide leadership and strategic oversight for a team of Safety Physicians and Scientists in the areas of safety surveillance, risk management and strategic product labelling ensuring optimal safety management of Mundipharma’s product portfolio across the product lifecycle.
Ensure compliance with all relevant Drug Safety regulations through application of relevant technical (safety strategic) expertise, leadership and effective collaboration with various internal and external stakeholders.

Drive optimal product labelling approaches that facilitate the safe and accurate use of Mundipharma’s products enabling product/portfolio differentiation and competiveness.
Promote a proactive risk-management approach and ensure application of industry best practice to drug safety across the Mundipharma network.
Ensure application of streamlined processes to drive a culture of continuous improvement in Mundipharma’s Drug Safety approaches
Develop an industry leading standard for drug safety management capability across Mundipharma’s associated companies worldwide to ensure optimal strategic and operational drug safety support for Mudipharma’s Business Development and partnership/alliance activities.

Location

Cambridge (UK)

Start Date

As Soon As Possible

Main tasks

• Establish and maintain a high-performing and industry-leading strategic safety epidemiology and strategic labelling capability.
• Drive innovative approaches to safety surveillance, risk management and product labelling to support Mundipharma’s portfolio of investigational and marketed products.
• Provide subject matter expertise and input to the clinical development programs in all drug safety related aspects including ongoing benefit/risk assessments
• Establish and maintain global standards in collaboration with the Mundipharma/Purdue group of companies for the Reference Safety Information for all products under development.
• Provide safety expertise and input to due diligence and business development activities.
• Oversee the development and maintenance of Company Core Data Sheets (CCDS) and related Core Company Safety Information (CCSIs) as basis for effective global approaches for optimal product labelling;
• Drive optimal interactions with regulatory authorities and other key stakeholders on all drug safety and labelling related issues.
• Definition of relevant KPIs and related quality standards linked to optimal safety stewardship of Mundipharma’s portfolio
• Establish a culture of performance, results focus and delivery within the Safety Strategy and Labelling teams.
• Key member of the Drug Safety and Regulatory Affairs leadership team contributing to the development of an industry-leading Drug Safety function.

Key Competencies

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Main requirements

QUALIFICATIONS/EXPERIENCE: An advanced scientific or medical degree, with extensive proven drug development experience pre and post registration. Extensive experience gained in a subject matter expert/leadership capacity in Drug safety including post-marketing pharmacovigilance in an international high-regulated pharma industry environment (pharma, biotech or CRO). Comprehensive knowledge of relevant legislation and guidelines including Good Pharmacovigilance Practice (GVP), GCP and ICH. Extensive experience in all aspects of investigational and post-marketing safety surveillance and risk management. Knowledge of emerging industry safety trends globally and practical experience of incorporating regulatory intelligence pertaining to drug safety requirements in non-EU countries/regions into product safety strategies would be an advantage. Basic understanding of and experience in utilising epidemiology approaches and tools in managing a portfolio of products across the product lifecycle. Experience in leading the delivery of competitive labelling outcomes across a portfolio of products is desirable. A broad understanding of working in a global multi-cultural environment in matrix organisational setting. KEY ATTRIBUTES: Exemplary leadership skills with both practical and short/long term strategic vision; ability to build relationships and inspire confidence and respect at all levels; strong team player. Excellent communicator – able to build rapport and demonstrate strong influencing and negotiation skills; excellent listening skills - receptive to feedback and demonstrates flexibility, curiosity and an ability to learn. Demonstrates and encourages ownership and responsibility; drive/motivation - has a “can-do” attitude and is committed to delivering results and strives for continuous improvement. Committed to continuous learning and improvement and ability to bring this culture to the team. A good blend of strategic and analytical thinking; innovative personality; able to see the bigger picture and set direction for the future. Consistently demonstrates and encourages others to demonstrate the Company’s Core Values; Honesty, Respect, Passion, Innovation and Commitment. Strong ethical standards and a high level of personal integrity. Adheres to the Company’s Compliance and Code of Business Ethics guidelines. Strong project management skills - demonstrated ability to work in a matrix organisation with cross-functional teams.

Contact Information

Name: Louisa Hodgson
Email: mr.hr@mundipharma-rd.eu
Telephone: 01223 424900
Adress: Mundipharma Research Limited
Unit 196 Cambridge Science Park
Milton Road
Cambridge CB4 0GW

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