Principal Drug Safety Specialist
Principal Drug Safety Specialist
Full time / Permanent
The life changer. The industry shaper. The healthcare pioneer. Join McKesson, a leading global healthcare company, and you can be all these things and more. Based from Coventry, as part of one of the teams shaping our services and improving lives, you’ll have the opportunity to drive your career forward and become more than you ever imagined.
About the department
Part of the McKesson group, at LloydsPharmacy Clinical Homecare we work in close partnership with the NHS and pharmaceutical companies to provide a huge range of care services to more than 80,000 patients in the comfort of their own home, at their place of work or in the community.
All of us, from children to parents, friends and partners, will take medicines at some point in our lives. The aim of pharmacovigilance is to ensure safer and more effective use of medicines for everyone. It involves all activities that relate to noticing, assessing, understanding, managing and preventing adverse effects of medicines for individuals and populations.
About the opportunity
To Provide effective support to enable the safe and prompt reporting of Adverse Events (AE’s) and Product Technical Complaints (PC’s) in respect of legislative and regulatory compliance products we supply.
- Complete each Pharmacovigilance (PV) activity effectively and ensure its safe flow through the PV reporting process.
- Assess when an AE/PC needs to be reported to a Pharmaceutical client based on their pre-defined requirements.
- Validate AE’s & PC’s received by the PV Team from clinical staff, customer services and the daily audit reports or any other source (PV mailbox, PV voicemail, etc.).
- Ensure all AE’s and PC’s are reported and quality checked within 1 business day or a 24 hour period from point of receipt to the relevant Pharmaceutical Client or the MHRA.
- Ensure all verbal or written queries relating to AE’s & PC’s from Pharmaceutical clients or the MHRA are handled accurately and in a timely manner, consistent with customer expectations.
- Support the reconciliation and audit process.
- Responsible for raising awareness to management where any deadlines are at risk, allowing remedial action to be taken to prevent late reporting.
- Contact colleagues (verbally or in writing), patients, healthcare professionals and other third parties (via telephone) to enable the effective reporting to clients.
- Maintain all mandatory training requirements including appropriate Pharmacovigilance training.
- Complete all documentation accurately and in the specified timescales.
- Work outside normal working hours, weekends and bank holidays as and when the need arises.
- Be an active member of the company’s Quality & Governance Team.
- Adhere to all Lloyds Pharmacy Clinical Homecare policies and processes.
- Work to the company’s quality standards and performance criteria.
- Ensure health and safety standards are adhered to at all times.
- Carry out any other duties as and when required.
Qualifications, training and experience:
- A degree in a science subject, HCP or 1 years equivalent practical experience.
- Administrative experience essential.
- Extensive Pharmacovigilance experience highly desirable.
- Experience of working within a process driven role or methodological environment.
- Working knowledge of Microsoft Office including Word, Excel, Outlook and PowerPoint.
- Have an appreciation of the importance of robust procedures for the benefit of patient safety and business reputation.
- An appreciation of data protection and handling confidential information.
- Good attention to detail and accuracy.
- Excellent written communication skills (written and verbal).
- Able to maintain high standards in a deadline driven, pressurised environment.
- Ability to work on own initiative and as part of a team.
- Ability to recognise when to escalate issues.
- Can do will do attitude.
- Ability to manage multiple and varied tasks and prioritise workload.
We’re McKesson – a Fortune Global 500 healthcare company that strives to break boundaries, challenge the status quo and support the changing healthcare industry. Bringing together six companies and 24,000 McKesson colleagues across pharmacy, pharmaceutical distribution and homecare services, we’re committed to offering the best advice and healthcare to our patients, customers and colleagues. As part of our UK Head Office you’ll be able to use your passion, ambition and drive to build solutions and have experiences that transform lives for the better – starting with your own.