Head of Medical Information and ABPI Compliance
|Job Title:||Head of Medical Information and ABPI Compliance|
|Start Date:||Q3 2018|
|Contact Name:||Vladyslav Babych|
|Job Published:||August 10, 2018 17:25|
*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 Business Unit UK/IE and Business Unit 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 Business Unit 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 Business Unit 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.
UK Registered Pharmacist qualification or MD
ABPI signatory (Final Signatory qualification)
Line management experience and leadership
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