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Senior Director, Global Pharmacovigilance

Greater Copenhagen, Denmark
BRIEF COMPANY PROFILE
Our client is a global, research-driven pharmaceutical company focusing on the development of prescription-only-medicines, and they are a global market-leader within their therapeutic area. The company headquarter is in Greater Copenhagen, Denmark with subsidiaries, production facilities and distributors worldwide.
 
THE POSITION
The Senior Director, Global Pharmacovigilance, will head up the pharmacovigilance function for all products and product candidates globally. The function will act as a key contributor to clinical development plans and manage all relevant reporting to global health regulatory authorities. Moreover, the role is responsible for determining the strategy for managing all operational processes and information systems supporting the Global Pharmacovigilance (GPV) function.

Reporting to the Senior Vice President, Global Pharmacovigilance & Clinical Development (GPCD) the position will take a seat on the GPCD management team while functioning as an advisor and subject matter expert on GPV related issues.

The Senior Director is expected to provide strategic leadership, be forward-looking and set a clear direction for the GPV team. Moreover, the candidate must possess a strong knowledge of global pharmacovigilance regulations, operational efficiencies, information systems, and best industry practices to effectively solve challenges and facilitate PV compliance. Additionally, the ideal candidate must possess a strategic mindset and be a true team player with a focus on creating an open, inclusive, and collaborative work environment.
 
POSITION PROFILE
Position title: Senior Director, Global Pharmacovigilance.
   
Reporting line:
 
Senior Vice President, Global Pharmacovigilance & Clinical Development (GPCD).
   
Reporting to the position: 4 Department Heads – all together 35+ employees.
   
Location: Greater Copenhagen.
   
Traveling:
  • Limited (mainly conferences, congresses, and key affiliates).
   
Responsibilities & Tasks:
 
  • Managing the GPV area, including on-going improvements in effectiveness and professional competencies within GPV.
  • Serving as a support and back-up to the EU-QPPV in relation to ensure oversight, structure, performance and maintenance of the pharmacovigilance system.
  • Acting as the pharmacovigilance contact point for competent authorities on a 24-hour basis in case of absence of the EU-QPPV.
  • In collaboration with the EU QPPV, ensuring and verifying that the Pharmacovigilance System Master File (PSMF) is constantly up-to-date and reflects the current pharmacovigilance system
  • Communicating immediately to GPCD SVP and EVP R&D in case of serious or important safety signals with a potential impact for our client’s existing business or development programs.
  • Representing our client’s PV in interaction with internal and external stakeholders (e.g., business partners), including communication of PV-related matters.
  • Responsible for implementing PV agreements with partners and distributors and ensuring compliance according to the agreements. 
  • Allocating sufficient GPV resources to projects and tasks.
  • Participating in GPV management and staff meetings.
  • Participating in GPCD management meetings.
  • Reviewing and giving input to quality documents within GPV and GCD.
  • Ensuring overall compliance within the GPV area while keeping oversight at all times.
  • Ensuring that SOP’s, Working Practices and Templates within the GPV area are maintained and updated.
  • Ensuring that systems and tools within the GPV area comply with applicable regulations and requirements.
  • Oversight of GPCD X-Board meetings.
  • Evaluating risk minimization measures to reduce risks of safety concerns (when required).
  • Reviewing business critical Signal reports, Aggregated reports, Risk Management Plans, and ad hoc reports as applicable.
  • Participate in safety related forums and committees as:
    • Safety Committee.
    • Medical director Forum.
    • Quality Board.
  • Taking part in keeping our client up to date with the international development within the pharmacovigilance field, including taking part in conferences and seminars in order to be updated regarding pharmacovigilance legislation.
   
Key success criteria:
 
  • Build and maintain a motivated GPV team that is appropriately trained and developed to meet professional requirements.
  • Develop and maintain a solid collaborative management team and broader organization within GPV. 
  • Plan and formulate long-term ambitions and strategy for the GPV area. 
  • Gain a comprehensive understanding of our client’s product portfolio.
  • Successfully contribute to driving a high-performance culture – based on a proactive and pragmatic mindset focused on adding value in collaboration with stakeholders.
 
CANDIDATE PROFILE
Educational background: MD or M.Sc. -level education within Pharmaceutical Sciences or related fields combined with relevant courses within drug development and pharmacovigilance.
   
Language: English – fluent (verbally and written).
   
Ideal experience:
  • 8+ years of management experience, preferably within the pharma/biopharma industry, alternatively within medical devices/IVD.
  • 8+ years of experience within GPV and GCP.
  • Skilled in all aspects of pharmacovigilance.
  • Thorough theoretical, practical knowledge and experience with regulatory requirements regarding marketed products and products in clinical trials.
  • Medical knowledge sufficient for evaluating specific individuals case safety reports and signals.
  • Demonstrated ability to work in cross-organizational management teams. 
   
Personal & leadership competencies: Collaborative
Is a team oriented bridgebuilder, works well with others with a view to obtain common objectives, shares information, resolve issues and improve efficiency; supports others and acts in a highly professional manner, seeing solutions rather than limitations.


Results and goal orientation
Exerts a strong personal drive while establishing visible and achievable goals for the department. Focus on action, activities and results. Is able to continue working at a specific problem, viewpoint or action plan until a result has been achieved or it is determined that an alternative approach is needed.

Long-term objectives
Prepares thorough project plans where goals as well as actions are clearly defined, breaks down a strategy into manageable tasks. Works with a long-term objective in mind.

Analysis
Divides problems into relevant parts; sensitively integrates the analytical output into the given context; differentiates between key areas and irrelevant and less important areas; has a logical mind-set; makes sensible decisions on the basis of available information; is able to get an overview of a specific situation and at the same time work detailed with a problem; uses details to gain an overview of a situation.


Visionary/strategic mind
Defines a clear vision. Looks beyond the immediate difficulties and focuses on the far-reaching consequences; sees things in a broad perspective; takes tendencies in the environment into account when planning and developing strategies.


Delegation
Delegates responsibility to the relevant employees and allows them room for manoeuvre to explore own initiatives, empowers people in order for them to carry out tasks efficiently.


Communication
Has excellent technical writing and verbal communication skills with a high level of proficiency in English. Produces written material that is clear, fluent, engaging and easy to understand. Has excellent cross-cultural communication and presentation skills and communicates the central issues in a discussion in a clear, fluent and precise manner, while being able to keep recipients' attention and is attentive to the needs of others when speaking.

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