Global Clinical Safety and Pharmacovigilance (Pharmaceuticals R&D)
Central Safety identifies, manages and communicates the safety profile of GSK products to enable informed benefit risk decisions helping people to do more, feel better, live longer. This analysis is conducted for medicines currently available on the market as well as novel medicines across all stages of clinical development.
The analysis of new safety data and the evolution of the understanding of benefits versus the risks of medicines is a rapidly changing scientific and regulatory field. Keeping abreast of new developments and ensuring GSK plays a leading role is a key area for the clinical safety group at GSK.
Join us, and you’ll get the chance to work with other functions across the business, to develop expertise so that you’re able to offer guidance to teams on important safety consideration for GSK’s medicines.
Clinical safety includes a diversity of responsibilities and fields of expertise that you will experience on our graduate programme.
Assignment structure for the three year programme
You will spend 18 months split between the Case Management Group (CMG) with 6 month options in either the Safety Data Exchange Agreements team (SDEA) or Systems Management Group (SMG). In addition, you will be assigned for 18 months in the Safety Evaluation and Risk Management(SERM) organisation comprising 9 months in 2 of the 3 SERM teams. These are further described below:
A rotation of 18 months experiencing:
Case Management Group (12 months)
At the frontline for new safety data, this group manages the global data reported to GSK. This section of the rotation will include first-hand experience of complex international data systems that capture and report new information.
Safety Data Exchange Agreement Group
You will learn to develop and oversee Safety Data Exchange Agreements (SDEA) which are legal written contracts that describe the processes to collect, report and exchange safety data with GSK’s external partners. Skills in compliance, influencing and negotiations would be developed.
Systems Management Group (SMG)
You will contribute to the pharmacovigilance system requirements including validation, support, maintenance and programming.
18 months experiencing 2 of the Safety Evaluation and Risk Management (SERM) teams
SERM teams focus on the identification, evaluation, communication and mitigation of risks associated with GSK products. Placing risks into the context of the benefits of a medicine is an important aspect of the role of a SERM scientist.
SERM Development/Classic and Established Products/Consumer Health
SERM development support projects in the early stage of their life cycle from first time in human studies to the immediate post-marketing period. Classic and established products support approximately 370 marketed products, across a wide range of therapy areas whilst SERM Consumer Health Care ensure that GSK products that are available over the counter are used by consumers in a safe and effective manner.
How will it help my career prospects?
What will I learn?
You’ll follow a structured development programme that incorporates business leadership and technical training in a role that gives an oversight of the life cycle of medicines that also provides a comprehensive introduction to the pharmaceutical organisation.
Where will I work?
The GCSP FLP is available in the United Kingdom at the Stockley Park site in Uxbridge, Middlesex.
What will be expected of me?
The programme will include developing skills that underpin the collection, evaluation and reporting of clinical safety data. This will include a series of diverse tasks and subsequently projects where you will be expected to demonstrate effective delivery, judgement and prioritisation according to the task at hand. You will need to build meaningful and effective working relationships with people at all levels of our organisation. In addition, we want you to proactively develop new skills and knowledge wherever you find the opportunity.
What do I need to succeed?
We’re looking for graduates or post-graduates with a Life Sciences degree with a minimum 2:1 grade. In addition, you’ll need an analytical mind, a talent for multi-tasking and the ability to influence others. You’ll also need ambition, a genuine interest in the pharmaceutical industry and a self-motivated, proactive approach. We’re looking for clear, effective communicators who can quickly build rapport with a wide range of people. It’s also important that you can adapt to change and keep focused when the pressure is on.
Whilst you have drive, you’re also a real team player who actively collaborates with others applying the values important to GSK’s culture of building trust, acting with integrity and always working to ensure the best interests of patients in everything you do.
Once you have completed the programme you will have a permanent role in the central safety organisation where careers in pharmacovigilance can progress in a variety of different ways. There are project leadership roles, process leadership roles, roles are available that focus on GSK’s ability to implement new regulations and cross functional activities that require a strong capability in leadership and project management skills. Finally, safety is an excellent platform to move into other areas such as regulatory or clinical as the central activities across the life cycle provide first hand insight and numerous transferable skill sets.
Global drug safety regulations are continually evolving, since 2010 there have been substantial changes including key international regions such as Europe and the US as well as bespoke requirements for individual countries. With expanding access to new data sources, there is an increasing expectation of oversight that is only just starting to be realised in the current digital age. The central safety area has to closely monitor and may need to implement new emerging technologies as required for this analysis.