Who We Are
Pharma Integrity is a leading provider of healthcare compliance services to pharmaceutical companies advertising prescription medicines in Ireland, the UK and Europe.
We work with clients predominantly based in Ireland and the UK, as well as Global organisations based in Europe, to provide expert advice on the interpretation and application of regulatory requirements; review and certify material and activities to be appropriate for use; establish frameworks, policies and procedures for companies to operate within; provide training; and inspection readiness analysis.
Working with Pharma Integrity, you will have the opportunity to bring new ideas to continuously improve our service and deliver real value to our customers every day.
Together we go beyond.
Our Vision
Our vision is to be the partner of choice to support life sciences companies to engage ethically, safeguard patients, improve outcomes and drive confidence in the industry We are proud to work with those who put the patient and patient safety first, and to be a trusted partner of choice.
Our Purpose
Driving the understanding and application of regulatory requirements surrounding the advertising of prescription medicines to ensure the right patients have access to the right treatments at the right time.
Our Values
Integrity
Excellence
Simplicity
Agility
Your Role
As a Healthcare Compliance Consultant, you will be primarily responsible for working with clients to understand and apply the regulatory requirements associated with the advertising of prescription only medicines in the UK and Ireland. The operational aspects of what is involved will vary between clients dependent on their needs.
Your Team
You will be working directly with other Healthcare Compliance Consultants, trusted contractors that provide services on behalf of Pharma Integrity, the Managing Director, and the CEO. You will report to the Managing Director.
Working Arrangements
You will primarily work at a location of your choice in Ireland or the UK whilst being available during core hours of 10:00-16:00. For those candidates living in Ireland, hybrid working arrangements are in place, with our offices located on Harcourt Street in Dublin. Candidates based in the UK can work remotely. You will be required to participate in monthly in-person team meetings in either Dublin or London (travel from and within the UK and Ireland will be supported). Flexible working arrangements may be considered for the right candidate.
Your Responsibilities
· Provision of advice and ad hoc/interim leadership in relation to regulatory requirements to clients
· Review and certification of client material and activities
· Drafting, review and input into the development and implementation of client policies and procedures
· Develop appropriate training material for use with clients
· Train cross-functional client teams on the interpretation and application of the regulatory requirements surrounding the advertising of prescription medicines in the UK and Ireland
· Day-to-day management of client needs
· Keep abreast of regulatory developments
· Assist in client audit / inspection readiness activities
· Advise clients on the implementation of company compliance standards
· Report at-risk deviations to clients and Pharma Integrity
· Support compliance investigations with clients
· Provide advice and leadership to clients in relation to compliance issues that arise
· Support and provide corrective and preventative actions to clients following compliance issues
· Draft reports as required
· Closely collaborate with client HR departments to support internal enforcement of compliance regulations
· Assess and identify business growth and commercial opportunities
· Occasional support with administrative & logistical arrangements surrounding meetings and events
Your Personal Attributes
· Positive work ethic
· Confident and enthusiastic
· Ability to work independently and as a flexible team player
· Proactive communicator
· Proactive working style
· Solutions-focused mindset
· Sound judgement and decision-making skills
· Good planning and organisational skills
· Excellent communication and interpersonal skills
· Willingness to learn
Your Experience
· Minimum 3 years’ experience in the commercial pharmaceutical industry, including considerable operational experience in Compliance and/or Medical Affairs roles in the UK
· Relevant regulatory experience as a reviewer or signatory with the ABPI Code of Practice for the Pharmaceutical Industry and MHRA Blue Guide. Experience with S.I. 541 of 2007, the IPHA Code of Practice or Medicines for Ireland Code of Practice desirable.
· Solid understanding of risk and compliance principles and frameworks
· Demonstrated cross-functional and stakeholder engagement experience
· Strong commercial acumen and ability to understand the impact of regulatory changes on commercial operations within pharmaceutical companies
· Ability to articulate and communicate risks associated with material and activities, and appropriate safeguards that can be applied to mitigate risks with a solutions-focused approach
Your Qualifications
Essential: As this role includes UK signatory responsibilities you must be a registered medic or a UK registered pharmacist and remain registered during the duration of your employment.
Your Package
· Competitive permanent salary
· Holiday entitlement calculated according to 0.8 FTE basis
· Pension
· Individual bonus / incentive scheme
· A genuine happiness coming to work each day – we care about YOU
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