Freelance​/Contract Responsible Person (RP) - Controlled drugs

For the past 25 years, Pro Pharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. Pro Pharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, Pro Pharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Pro Pharma is currently supporting a life-sciences brand in the UK where they are looking to appoint their site responsible person for their controlled drug license. This project will commence immediately; it is to run for at least 12 months and on average it requires 1-2 days per week support throughout. The successful Consultant will have demonstrated experience working as a Responsible Person and be a registered Pharmacist.

• Act as the designated Site Responsible Person for the Controlled Drugs Licence.
• Maintain oversight of compliance with Home Office Controlled Drugs Licence requirements and applicable controlled drugs legislation.
• Serve as the primary point of contact for matters relating to the controlled drugs licence and regulatory inspections
• Support licence applications, renewals, amendments, and ongoing maintenance activities.
• Ensure all controlled drugs activities are conducted in accordance with legal, regulatory, and organizational requirements.
• Provide oversight of the procurement, receipt, storage, supply, administration, transport, record-keeping, and destruction of controlled drugs.
• Establish and maintain appropriate governance frameworks, policies, and procedures for controlled drugs management.
• Lead investigations into controlled drugs discrepancies, losses, incidents, and deviations.
• Conduct periodic self-inspections, audits, and compliance reviews.
• Ensure ongoing inspection readiness and support responses to regulatory findings.
• Act as the lead pharmacist supporting the sourcing and procurement of controlled drugs and other medicinal products.
• Establish and maintain relationships with licensed wholesalers, pharmacies, manufacturers, and suppliers.
• Advise on legal routes of supply, sourcing strategies, and medicines procurement processes.
• Support supplier qualification and oversight activities.
• Provide expert pharmacy input to ensure continuity of supply and compliance with medicines legislation.
• Review and approve SOPs relating to controlled drugs and medicines management.

• A University degree in Pharmacy.
• Must be a registered Pharmacist with General Pharmaceutical Council (GPhC).
• Must have demonstrated exposure working as RP/RPI.
• Demonstrated skills working with controlled drugs and the home office.
• Can perform the position requirements as set out in the job description.
• Can commence a new project in the next few weeks with more hours needed in the initial stages.
• Thorough understanding of the GDP landscape in the UK is a must.

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