Head of Safety Strategy, Labelling and Compliance

Leiter Sicherheitsstrategie, Kennzeichnung und Compliance

Job Introduction

Provides overall leadership and strategic oversight for safety surveillance, risk management, compliance and product labelling ensuring optimal management of all safety aspects of Mundipharma’s portfolio across the product lifecycle.
Ensures compliance with all relevant Pharmacovigilance regulations through leadership and oversight of Mundipharma’s Drug Safety & Pharmacovigilance Quality Management Approach/System.
Drives optimal product labelling approaches that facilitate the safe and accurate use of Mundipharma’s products and enables product/portfolio differentiation and competiveness.
Promotes a proactive risk-management posture across the Mundipharma network that is informed by industry best-practice and underpinned by a culture of innovation and continuous improvement.

Location

Cambridge (UK)

Start Date

As Soon As Possible

Main tasks

Establish and maintain a high-performing and industry-leading strategic safety, labelling and compliance capability able to support development and commercialisation of a varied portfolio of products globally.
Drive innovative approaches to safety surveillance, risk management and labelling strategies and actions to support Mundipharma’s portfolio of investigational and marketed products.
Provide safety expertise and input to due diligence and business development activities
Provide strategic safety leadership and expertise into shaping and executing clinical development programs. Ensure strategic input and high quality safety data analysis to optimize development of Mundipharma’s pipeline assets.
Ensure a robust safety surveillance system for investigational products encompassing clinical trial safety surveillance; Investigational Brochure (IB) development; ISS review; DSUR reporting; development of CCSI; development of product labelling; overall management of drug safety for individual studies.
Drive optimal interactions with regulatory authorities and other key stakeholders on safety, pharmacovigilance and labelling related issues.
Responsible for the development and maintenance of a global Pharmacovigilance Quality Management Approach/System ensuring development and adherence to Standard Operating Procedures (SOPs), monitoring and reporting of Compliance metrics and oversight of Corrective Action Plans (CAPAs).
Manage and maintain a regulatory compliant Pharmacovigilance System Master File (PSMF)
Ensure a robust system for Mundipharma Pharmacovigilance and Regulatory Agreements (PVAs) in line with regulatory, legal and business requirements; establish/maintain a contact network to the Pharmacovigilance Responsible Persons of Independent Associated Companies and Third Parties.
Ensure provision of safety surveillance advice and training within Mundipharma network of Companies to ensure adequate knowledge transfer and to embed industry best practice.
Work closely with the EU-QPPV, to provide support/data for Pharmacovigilance Audits and Inspections, and contribute to inspection readiness and proactive Compliance culture.
Establish a culture of performance, results focus and delivery within the Safety Strategy, Compliance and Labelling teams.
Key member of the Drug Safety and Regulatory Affairs leadership team contributing to the development of an industry-leading Drug Safety and Regulatory Affairs function.

Key Competencies

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Main requirements

Qualifications & Experience
A medical degree, with significant post registration experience (clinical, academic and/or pharmaceutical) including proving experience of working within pharmacovigilance in an international high-regulated environment
Ideally a post-graduate qualification or accreditation reflecting a higher level of medical training
Comprehensive knowledge of relevant legislation and guidelines including Good Pharmacovigilance Practice (GVP), ICH and GCP.
Extensive experience in all aspects of investigational and post-marketing safety surveillance and risk management. Experience in leading the delivery of competitive labelling outcomes is desirable.
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.
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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