Laura - Medical
Pharmacovigilance (PV) Manager
Number of years in role: 4.5 years
I gained my degree in South Africa, where I then went on to work as a pharmacist for a number of years. On arriving in the UK I initially worked in medical information, but found telephone work wasn’t for me. Opting to work in drug safety, I was contracted to a number of big pharmaceutical companies, when in 2005 I came to sanofi-aventis to manage a team in drug safety. PV is all about protecting patients by ensuring that we are always aware of the safety profile of our company products. As such this is a legal requirement, so processes and compliance are key.
Arrived at 8.45am and connected my computer to the docking station. Whilst it’s booting up I take the opportunity to read the latest “Management Today”. Following on from Friday, I have to catch up with the team on the case that I had to finish, so we cover this off as well as running through an agenda for the coming week
I’m then off to a meeting with my manager and the Quality department to discuss the implementation of a new PSUR database. This is followed by giving some training to our newest member of the team on the submission of patient reports to the MHRA and then I’m back in with my boss and a colleague to discuss workloads.
I grab some lunch and then get straight onto an adverse event report that needs my attention, which I manage to clear up after a few calls. No time to pause, as I then meet with team members to catch up on some day-to-day matters (SOPs, training and a contract we’re drawing up).
I then deal with a request to review a protocol for the safety reporting of a new clinical trial that is being run by the clinical department, by which time the medical director’s PA kindly comes around with some carrot cake that’s been left over from a meeting which I gladly volunteered to help finish. My last task of the day is reviewing an Incident report to the MHRA regarding one of our products.
There were two accidents on the road to work so I’ve arrived at the office late and frustrated. Before I have a chance to put my bag down, I have Quality asking to speak with me about the validation of the new PV database and a member of the team asking if I had reviewed the safety data exchange agreement that we are about to supply to a partner company. Luckily when I look at my calendar, I have no meetings booked for the day – so I go through my emails and start to order my day.
I notice I have been asked by our clinical team if I could provide training to their project leaders on post authorisation safety studies, so I have a quick review of slides and training materials to conduct the session.
The day gets swallowed up in a number of tasks; from discussions with the communications department on their service provider for literature searching to see if we could get a better service then what we are currently receiving, to a request from Clinical to review another protocol and give my signature and finally a signal generation meeting with the team to determine if any signals have been noted for any of our products over the last few months.
I have a meeting lined up with Quality on the validation procedure required to implement a new database. As is typical, I have an informal catch up with the team to discuss any issues that have arisen in the course of the week. Then it’s back with Quality to discuss a counterfeit case and then onto processing adverse event reports received during the day and investigating a compliance issue.
After lunch there’s a minor crisis in the department, as some cases are noted late – which then requires processing immediately, so I work with the team to manage the actions. Finally, we’re only a month away from launching a new safety database, meaning all our procedures need updating and rewriting. It’s towards the end of the day that I take the opportunity, to pause and sit at my desk to start writing.
Today we had a long meeting to review our future case flows and processes with the arrival of a new safety database. It took up a large part of the day, but there was still time to fit in a one-to-one with one of my team and prepare an induction plan for another new starter as well as plan the team rota for next week. The day finished off with a review of a PSUR for submission to the MHRA and then it was home time.
Friday is a manic day in PV. We officially work one hour less for a start as we have an early 4pm finish on a Friday (although I sometimes start early to get ahead!) and, for some reason, we always get more work than usual. What’s more, because our timelines are regulated in compliance with the Health authorities, most of our case reports have to be done today, so it’s buzzing.
I started the day by contacting Winthrop (our generics business) regulatory division, to see if I can book myself in for a quick chat on the Nifedipine issue which requires a pressing PSUR (periodic safety update report - a document that discusses the safety profile of a product over a period of time).
There’s a scheduled training session at 11.30am on the new quality system managing our SOPs (standard operational procedures) but first I need to induct a new team member on PSUR’s. Following the induction and QSD (quality system design) training (which ran on until 1pm), I have a quick bite at my desk and then I’m straight to my manager’s for my one-to-one (which extended to discussing department projects, training etc).
Three valuable hours later, I return to my desk, only to find a pile of paperwork which needs my signature as well as a case report, which had not yet been submitted to our corporate colleagues from our team and the deadline’s today! I carefully completed it and faxed it to corporate. Home time!