Director of Vigilance

Direktor der Vigilanz

Job Introduction

Provide expertise, strategy as well as a hands-on approach to safety surveillance & risk management, epidemiology and in-licencing opportunities within the company.
Responsible for the company’s approach towards risk management to minimize the safety risk towards patients.
Responsible for the development, coordination and execution of epidemiology/ pharmaco-epidemiology strategy across projects and throughout all phases of product lifecycle.
Drive the safety strategy as it relates to review of product opportunities
Responsible for providing comprehensive review and analysis of the safety of the Company’s products including both marketed drugs and those in clinical trials, to ensure consumer, prescriber and regulatory authority confidence.

Location

Cambridge (UK)

Start Date

As Soon As Possible

Main tasks

·        Safety surveillance
o   Act as safety expert for assigned active moieties in clinical development, managing drug safety and pharmacovigilance for the clinical programme. This may encompass but is not limited to the following activities:
§  Clinical trial safety surveillance (signal detection; signal evaluation; benefit risk assessment; risk mitigation)
§  Review of clinical trial documentation
§  Responsibility for RSI development and maintenance as well as periodic reports (DSURs)
o   Act as safety expert for assigned products, managing post-authorisation safety surveillance. This may encompass but is not limited to the following activities:
§  Post-marketing safety surveillance (signal detection; signal evaluation; benefit risk assessment; risk mitigation)
§  Authoring safety sections of periodic reports and safety reports (e.g. PSURs)
§  Risk management (including compilation of Risk Minimisation Plans (RMPs))
§  Responsibility for CCSI development and maintenance  
·        Develop and lead strategies to advance risk management within drug safety.
o   Ensure compliance of processes with international regulation and guidance.
o   Develop smart communication strategies of risk and risk management activities
o   Design, develop and ensure oversight of individual risk management strategies for individual products
o   Represent VRM in interactions, relating to pharmacovigilance topics, with governmental agencies and other competent authorities
o   Prioritize activities across multiple projects and effectively negotiates plans with colleagues and customers.
·        Epidemiology
o   Lead all aspects of epidemiology expert input to development and maintenance of products
o   Lead epidemiologic literature searches as well as support analyses of epidemiologic data sets to aid business planning, ad hoc queries, and aggregate reports
o   Design, develop and ensure oversight of observational studies to describe and quantify disease epidemiology, safety aspects of real-world usage of drugs, and effectiveness of risk minimization activities
o   Maintain up-to-date knowledge of industry best practices in epidemiology and recognized as internal expert and go-to person
o   Collaborate with Publication team to align and support publication strategy and dissemination of research findings at conferences and peer review journals
o   Assist in the development and establishment of processes and procedures to maximize strategic and operational excellence
o   Identify, select, establish and manage a global network of contractors, consultants, and CROs to execute planned epi deliverables
o   Develop and maintain a strong network of professional contacts
·        Evaluate inlicensing opportunities and support innovation process for new business opportunities and acquisitions
·        Provide comprehensive benefit/risk assessment throughout the life of the Company’s products (clinical development and post-marketing).
·        Provide strategic medical safety knowledge in other areas throughout the business
·        Ensures that all tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and timeliness; and in accordance with current global regulatory requirements, guidelines, and cost effectiveness goals.
·        Utilise comprehensive knowledge and experience to ensure all work is conducted in accordance with current international, regional and national legislation and guidelines, including Good Pharmacovigilance Practice (GVP), ICH and GCP
·        Live a leadership culture of organisational performance and delivery, by focusing on high priority core activities and behaviours to help build and shape the business that will drive the future success of the company.
·        Train, mentor and develop people to deliver consistent and high quality safety support

Key Competencies






Main requirements

Qualifications & Experience
·      University degree in medicine with some specialization
·      PhD in epidemiology is strongly preferred, at least a Masters level degree required
·      Proven experience in pharmaceutical/biotechnology industry in pharmaco-epidemiology or similar function
·      Significant experience in safety surveillance and risk management essential
·      Proactively understands regulatory framework, trends &requirements related to epidemiology, risk management, products, clinical studies and global drug development
·      Detailed working knowledge of applicable legislation and guidance
Personal & Leadership Characteristics
·      A resourceful, integrative thinker with the ability to look for pragmatic solutions
·      Thrives working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
·      Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
·      Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
·      Outstanding commitment, accurate and methodical approach to work, great sense of responsibility and reliability
·      Ability to work and prioritise under pressure, self organisation skills, confident and competent to take lead role
·      Ability to work both autonomously and as part of a team
·      Very good 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.
·      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 project management skills - demonstrated ability to work in a matrix organisation with cross-functional teams
·      Strong ethical standards and a high level of personal integrity.

Contact Information

Name: Louisa Hodgson
Email: mr.hr@mundipharma-rd.eu

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