Safety Evaluation Scientist-Literature
Safety Evaluation Scientist-Literature
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Job Description
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Relevant Years of experience 3 to 6 years.
Perform PV literature surveillance assessment activities according to regulations and agreed processes.
Timely production of key deliverables including but not limited to:
Screen and review literature search results (articles/abstracts/citations) for aggregate report inclusion and potential safety signal identification.
Maintain and document uptodate product knowledge for literature evaluation.Participate in quality or continuous process improvement activities related to area of responsibility
Discusses need for and priority of safety related findings/ signal reviews with the SERM product specialists / SERM physician communicate escalate and document the outcome of signal detection process.
Analyse and discuss safety data results with the SERM product specialists/ SERM physician and other key stakeholders
Know where to find relevant safety information on products.
Familiar with aggregate reports (DSURs PBRERs) Risk management activities (RMPs) labelling documents (GDS DCSI)
Demonstrate GSK values
Job Related Experience:
Pharmaceutical industry experience (e.g. drug safety (desired) regulatory clinical development medical affairs)
Basic knowledge of postmarketing regulations applicable to drugs.
Knowledge of the principles of causality assessment and the evaluation of safety signals.
Serviceoriented attitude and ability to be a team player and interact effectively with all levels of personnel in an interdisciplinary and matrix environment.
Working knowledge of key pharmacovigilance regulations and methodologies
Basic knowledge of medical and drug terminology.
Basic understanding of therapy areas of assigned products.
Basic knowledge of some other relevant disciplines (e.g. statistics pharmacoepidemiology).
Experience in scientific literature review data gathering data synthesis analysis and interpretation.
Knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities.
Excellent English language skills written and verbal particularly in scientific/medical terminology
Ability to evaluate data and draw conclusions independently
High attention to detail.
Highly developed interpersonal presentation and communication skills.
Computer proficiency IT skills the expertise and ability to work with webbased applications
High level of flexibility and ability to prioritize work
Why GSK
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus Transparency Respect Integrity along with Courage Accountability Development and Teamwork. As GSK focuses on our values and expectations and a culture of innovation performance and trust the successful candidate will demonstrate the following capabilities:
Operating at pace and agile decisionmaking using evidence and applying judgement to balance pace rigour and risk.
Committed to delivering high quality results overcoming challenges focusing on what matters execution.
Continuously looking for opportunities to learn build skills and share learning.
Sustaining energy and wellbeing.
Building strong relationships and collaboration honest and open conversations.
Budgeting and costconsciousness.
Inclusion at GSK:
As an employer committed to Inclusion we encourage you to reach out if you need any adjustments during the recruitment process.
Please contact our Recruitment Team at to discuss your needs.
Why GSK
Uniting science technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose to unite science technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger more sustainable shareholder returns as an organisation where people can thrive. We prevent and treat disease with vaccines specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies investing in four core therapeutic areas (infectious diseases HIV respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders its also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome valued and included. Where they can keep growing and look after their wellbeing. So if you share our ambition join us at this exciting moment in our journey to get Ahead Together.
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Employment Type
Full-Time
