Pharmacovigilance Scientist / Drug Safety Scientist
- London, (GBR)
- £54 - £59 Per Hour
- 12 Months
- Start date: ASAP
- Ref: gsk-23117
- pharmacovigilance
- safety management
- regulatory
- drug
- statistics
- risk management
- hiv
- r&d
- approval process
- regulations
Role Title: Pharmacovigilance Scientist
Duration: 12 Months
Location: GSK London
Rate: £59 per hour - Umbrella (7.5 hour days)
Who Are We - GSK?
We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GlaxoSmithKline plc was formed in 2000 as a result of a merger between Glaxo Wellcome plc and SmithKline Beecham plc, although our history can be traced back more than 300 years to London’s Plough Court Pharmacy in the 1700s.
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. Our strategy is to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our three global businesses, scientific and technical know-how and talented people. Our values and expectations are at the heart of everything we do and form an important part of our culture:
• Our values are Patient focus, Transparency, Respect, Integrity
• Our expectations are Courage, Accountability, Development, Teamwork
Role purpose / summary
We are seeking a Pharmacovigilance Scientist for the Safety Evaluation and Risk Management (SERM) team within GSK’s Global Safety Department, specifically aligned to support products in the GSK ViiV portfolio (HIV). Day-to-day, you will work hands on in monitoring and evaluation of safety profiles to ensure optimal decisions are made with safety in mind. In this role you will be performing routine pharmacovigilance activities such as signal detection/evaluation, authoring key regulatory documents, managing regulatory requests and more.
As a Scientist, you will also play a strategic role, driving discussions and improvements in safety management. You’ll present findings to senior stakeholders and governance bodies and must therefore be comfortable engaging with colleagues at all levels of the organisation. This position offers the successful candidate the chance to develop your expertise, and making a significant personal impact on the safety of HIV products. You’ll, you’ll work with a highly skilled and supportive team – a group where individuals help one another both in their progression and growth, and in their regular activities.
Key Responsibilities include, but are not limited to:
• Assisting with the monitoring and evaluation of safety profiles for allocated products to ensure that optimal decisions are made at all stages of the product lifecycle
• Conducting routine pharmacovigilance activities(knowledge of the CommonWealth Vigilance Workbench would be advantageous, literature review and, in partnership with safety physician, tools for individual case awareness for all products in area of responsibility), signal detection/evaluation and leading authoring of key regulatory documents (e.g. DSURs, EU RMPs and PBRERs)
• Ensuring that all safety documentation is accurate and available to meet global compliance and regulatory requirements
• Driving discussions and the management of safety issues within the wider safety team
• Leading presentation of safety-related findings to senior stakeholders (including Vice President and Senior Leadership Teams) and to ViiV’s governance bodies#
Key Skills/ requirements
This role is within the Global Safety Department and you will need to be highly self-motivated with a true passion for pharmacovigilance. You will also be resilient and calm under pressure, with strong interpersonal skills, and a continuous improvement mindset. You will be comfortable working with complex matrix organisation, as you will frequently collaborate with safety staff and other groups outside of safety, including leaders throughout ViiV’s R&D division. We need someone in this role who is comfortable working at pace and who can deal with change.
All profiles will be reviewed against the required skills and experience. Due to the high number of applications we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply!
• Bachelors, or above, degree in Biomedical or Health Care related speciality
• Experience in scientific literature review, data gathering, data synthesis, analysis and interpretation
• Competent medical/scientific writing skills
• Sound computing skills Knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities.
• Knowledge and experience\e of the principles of causality assessment and the evaluation of safety signals
• Basic understanding of the HIV therapy area would be an advantage
• Basic knowledge of some other relevant disciplines (e.g. statistics, pharmacoepidemiology)
• Basic knowledge of medical and drug terminology
• Basic understanding of drug development process
• Basic understanding of drug approval process in major countries
Join GSK’s vision to do more, feel better and live longer:
https://www.youtube.com/user/gskvision/
Who will I be working with?
http://www.gsk.com/en-gb/careers/meet-our-people/
