As Director, Head Pharmacovigilance (PV) Policy you will be responsible for leadership and daily oversight of the PV policy activities in Global Medical Safety (GMS).
You will be responsible for monitoring the current pharmacovigilance regulatory environment for opportunities to shape future PV regulations, guidance, policy and legislation. You will act as a key liaison for GMS with internal and external stakeholders on PV-specific regulatory topics, and will lead efforts to identify emerging regulatory and legislative issues that impact global PV operations.
You will communicate key changes to GMS senior management, oversee the implementation of process changes needed for compliance with new or updated regulations and provide progress reports in the form of a dashboard to the PV Policy Committee. In addition, you will be responsible for the operational aspects of the PV Policy Committee, leading and participating in internal and external working groups as needed, developing and maintaining a PV intelligence network, and supporting trade association and Health Authority connections.
You will be responsible for providing leadership and support in monitoring regulatory environment for changes affecting the PV system and ensures implementation of the necessary process changes to be compliant with new or updated regulatory requirements and the development and implementation of strategic plans and projects. You will need to be skilled at assessing data and information, shaping communication, and developing and executing strategy. Demonstrated experience in communication, implementation of strategic initiatives, cross-cultural activities, and experience in the development and implementation of process changes and policy initiatives is required.
Additionally you will –
Have the ability to proactively identify issues and problems, assess risk and offer solutions and recommendations and communicate to senior leaders in GMS
Able to influence functions and working groups to ensure assessment of new or updated regulatory requirements and implementation of necessary changes
Make complex decisions that resolve regulatory compliance or business issues and demonstrate acute understanding of the impact of decisions taken
Interpret the applicability of PV regulatory guidance and processes to propose innovative solutions to compliance challenges and areas of PV policy
Ability to work across different businesses and cultures on a worldwide basis to ensure global alignment and compliance with key stakeholders
Develop effective and highly communicative relationships across highly complex organisations of multifunctional personnel
Exercise excellent judgment in assessing priorities
As Director, Head PV Policy, your typical day may include:
Responsible for leadership and daily oversight of PV Policy activities within the Global Medical Organisation including:
Overseeing activities to identify, report and implement changes and emerging trends in the global PV regulatory environment impacting the PV system and ensure compliance with global regulatory requirements through
Monitoring global regulatory environment for new or updates to PV policies, regulations, guidance and legislation (‘regulatory requirements')
Co-ordinate the assessment of the above for impact on Janssen processes
Communicate the new or updated regulatory requirements with impact on Janssen processes to senior leaders in GMS
Oversee the implementation of process needed for compliance with new or updated regulatory requirements by maintaining oversight of PV Policy working groups assessing key policy issues and regulatory changes impacting the global PV system
Developing and implementing strategic plans for PV Policy and intelligence activities in GMS
Identifying opportunities to drive PV intelligence initiatives forward in order to improve GMS efficiency and organisational effectiveness
Chairing the GMS PV Policy Committee and maintaining Committee processes and procedures
Ensuring effective communication of key changes in the PV Regulatory landscape to GMS senior management and other internal stakeholders
Provide progress reports on the above implementation plans to senior leaders in Global Medical Safety
Build and maintain a network of internal and external stakeholders to accomplish PV Policy strategic goals
Participate in and lead cross-functional teams working on strategic deliverables relevant to global regulatory intelligence and policy and cross-sector collaboration within JNJ regarding PV Policy matters
Desired Skills and Experience
You must have a minimum of a Bachelor’s Degree preferably in science, health policy, health sciences or business field. Master’s Degree in appropriate discipline or MBA is preferred.
Must have solid project management experience (or equivalent) and proven capacity to work in a matrix organisation.
Demonstrable experience in Pharmacovigilance
Ability to influence various functions within and outside of GMS and implement needed process changes
Strong critical thinking, analytical and problem solving skills
International experience is a plus.
Demonstrated networking skills - including ability to interact with internal staff, other company affiliates, as well as external clients/customers/service providers
Communication - both verbal and written in a credible and effective way.
Ability to facilitate J&J/GMS strategy, positions and policies effectively to promote J&J position in health leadership
Results oriented with good listening, conflict resolution, negotiation, and interpersonal skills.
Languages: Excellent written and spoken English required. Additional language skills are a plus.
What we’re about:
Global Medical Safety is a functional area within the Global Medical Organization.
QPPV and IPV Office: This position will be an integral part of the QPPV and IPV Office team and will interact with other team members on a daily basis to progress projects and programs and achieve results.
This position will interact with the following internal functions on a regular and ongoing basis as part of principal responsibilities. Interactions may become more frequent during projects to achieve specific goals related to PV Policy & Intelligence
International PV
GMS functional leadership and subject area experts
EU and Global Med Affairs
Global Regulatory Affairs
Government Affairs
Cross sector PV Policy groups
This position may occasionally interact directly or indirectly with external trade associations and professional bodies to support company activities and representatives to PV related subcommittees or working groups
External trade associations (e.g. Bio, PhRMA, EfPIA, EBE)
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