Deadline: February 28, 2020 Head of Compliance UK/IE

Pharmacosmos is a specialist in iron deficiency management and our aim is to become the partner- of-choice by improving patient outcomes and optimising productivity related to iron deficiency and iron deficiency anaemia management. 

The Head of Compliance UK/IE is responsible for operational leadership of the Compliance, Medical Information and Pharmacovigilance team and the team members alignment to the Pharmacosmos UK/IE strategy.

The role reports to the Medical Director UK/IE.

Responsibilities


  • Operational leadership of the Compliance, Medical Information and Pharmacovigilance functions.
  • Partake in the approval and sign-off of items submitted for compliance approval.
  • Operational excellence within each function: Define and track via individual and functional key performance indicators linked to company strategy and objectives.
  • Provide input to other Pharmacosmos UK/IE and Pharmacosmos International functions to ensure compliance of UK and IE promotional / non-promotional materials and activities.
  • Maintain oversight of adherence across company activities to the ABPI/ IPHA codes of practice, other codes, laws and regulations (Data protection, Health and Safety, Training, Conflicts of interest, Antifraud, Anti Bribery Act, Anticorruption, Competition Law, PV reporting, Employment law and global policies etc.
  • Keep up-to-date on requirements in relation to Compliance, Medical Information and Pharmacovigilance (i.e. ABPI, PMCPA and MHRA etc).
  • Foster and maintain a culture of compliance, through the deployment of engaging training, awareness and education programs covering all the required codes and other regulations.
  • Be the Final Signatory for the approval of UK/Ireland promotional and non-promotional materials and activities in accordance with regulations and codes of practice.
  • Delivery of disclosure declarations as necessary for transparency in line with the ABPI and IPHA Codes of Practice and company policies.
  • Ensure optimal use of the IT systems used by Pharmacosmos UK/IE in relation to Compliance, Medical Information and Pharmacovigilance.
  • Ensure timely and relevant compliance and pharmacovigilance training to sales, market access and medical affairs team aligned with global communication strategy, product positioning and target therapeutic areas.
  • Budget management of Compliance, Medical Information and Pharmacovigilance. Budget approved by Leadership Team.
  • Procedures: Timely implementation of, and at all times adherence to, all SOPs relevant to Compliance, Medical Information and Pharmacovigilance functions.
  • Pharmacovigilance: Fulfil the responsibilities as defined by the pharmacovigilance SOPs related to medical enquiries and drug safety information.
  • Support Pharmacosmos HQ in relation to pharmacovigilance implementation and audits.
  • Lead compliance related audit activities and ensure timely response to findings; oversee remedial actions; i.e. external or global audit – coordinating training and training records, Veeva PromoMats, HCP sponsorships, SOP status, audits and monitoring, HCP TOV transparency and GDPR.
  • Lead on the maintenance, update and communication of key processes, SOPs, policies, training, non-compliances and improvement activities for audit activities such as Code compliance, ad hoc, training, disclosure assessment, social media monitoring.
  • Create appropriate networking relationships with other affiliates, head office and externally.
  • Manage compliance processes and key controls including developing and reporting on Key Performance Indicators.
  • Respond to alleged breaches of rules, regulations, policies, procedures, and Standards of Conduct by evaluating or recommending the initiation of investigative procedures.
  • Regularly review compliance policies and processes and conduct regular reviews of their compliance activities across the business to identify any vulnerabilities and risks and develop and implement any remedial plans.
  • Have oversight in the maintenance of department databases and standard medical information responses.

Time Management


The Head of Compliance UK/IE will spend 60% of their time working on Compliance approvals, 30% of their time on people management within the Compliance, Medical Information and Pharmacovigilance functions, and 10% of their time reporting to the Medical Director (line manager) as well as functional reporting to the Leadership Team.

Objectives and Performance Review


Objective setting and performance review for the Head of Compliance UK/IE, and the Compliance, Medical Information and Pharmacovigilance functions, will take place minimum once yearly as per the company’s appraisal system.

Competencies


  • Leadership – ethical, ambitious, focused, organised
  • Customer-oriented – analyse and meet/exceed customers’ needs
  • Drive – “prompt call-to-action”
  • Responsible – timely and explicit feed-back to customers on agreements
  • Transparency – flat decision structure and communication
  • Accountability – Independent decision-making (impartiality, competence and ethics)
  • Ability to act locally, also in accordance with main prioritisations of the company

Attitude and Behaviour


  • Proud Pharmacosmos ambassador
  • Strong personal leadership
  • Inspire cross-functional transparency and collaboration
  • Customer-centric ‘can-do’ attitude and goal focused
  • Ambitious, independent, analytical, collaborative, loyal, organised

Professional Background


  • The ideal candidate is a Medical Doctor or registered Pharmacist and has demonstrated commercial and marketing acumen
  • Holds good understanding of the workings of the pharmaceutical industry
  • Extensive knowledge / proven track-record in Compliance, Medical Information and Pharmacovigilance functions
  • Detailed working knowledge and understanding of the ABPI Code of Practice and the appropriate regulations and policies
  • The individual would require a strong drive with excellent leadership, collaborative mind-set and great communication skills

Authority


The Head of Compliance UK/IE has full authority to manage and carry out campaigns and projects as approved by the Leadership Team and will act on their own initiative to achieve set objectives.

Flexibility


All roles at Pharmacosmos can and will reasonably evolve their duties and responsibilities over time, reasonable flexibility is therefore a key part of any job at Pharmacosmos. Significant variations in duties and responsibilities should be discussed between the post-holder and manager as they occur.

Innovation


Even if not specifically stated in the job description, all employees are encouraged to improve and innovate their own roles as well as to highlight improvements and innovations that may be made elsewhere. Agree with your manager how such innovations may be raised or implemented.

Geography and Travels


Office based, covering UK and IE. Occasional travel to international congresses and Pharmacosmos HQ in Denmark.

About Pharmacosmos


Headquartered in Denmark, Pharmacosmos is a family-owned, international healthcare company with more than 50 years of innovation and leadership in iron- and carbohydrate-based treatments and solutions for human and animal use.

A research-based company, its ongoing R&D programme focuses on improving the lives of patients with iron deficiency with or without anaemia. More than 1 billion people live with iron deficiency anaemia and it is the leading cause of death for an estimated 180,000 people every year. This makes it one of the largest global health challenges of our time.

Pharmacosmos has subsidiaries in the Nordics, the UK and the US and its products are marketed in more than 80 countries across the world. Its manufacturing facilities are approved, among others, by the Danish Medicines Agency and the US FDA.

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