Safety Evaluation Scientist-literature

2 weeks ago


Bangalore Karnataka, India GlaxoSmithKline Full time

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 up-to-date product knowledge for literature evaluation Participate in quality or continuous process improvement activities related to area of responsibilityDiscusses 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 stakeholdersKnow where to find relevant safety information on products Familiar with aggregate reports DSURs PBRERs Risk management activities RMPs labelling documents GDS DCSI Demonstrate GSK valuesJob Related Experience Pharmaceutical industry experience e g drug safety desired regulatory clinical development medical affairs Basic knowledge of post-marketing regulations applicable to drugs Knowledge of the principles of causality assessment and the evaluation of safety signals Service-oriented 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 methodologiesBasic 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 terminologyAbility to evaluate data and draw conclusions independentlyHigh attention to detail Highly developed interpersonal presentation and communication skills Computer proficiency IT skills the expertise and ability to work with web-based applicationsHigh level of flexibility and ability to prioritize workWhy GSKOur values and expectations are 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 decision-making 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 well-being Building strong relationships and collaboration honest and open conversations Budgeting and cost-consciousness 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 GSKUniting 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 Important notice to Employment businesses AgenciesGSK does not accept referrals from employment businesses and or employment agencies in respect of the vacancies posted on this site All employment businesses agencies are required to contact GSK s commercial and general procurement human resources department to obtain prior written authorization before referring any candidates to GSK The obtaining of prior written authorization is a condition precedent to any agreement verbal or written between the employment business agency and GSK In the absence of such written authorization being obtained any actions undertaken by the employment business agency shall be deemed to have been performed without the consent or contractual agreement of GSK GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses agencies in respect of the vacancies posted on this site It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way GlaxoSmithKline does not charge any fee whatsoever for recruitment process Please do not make payments to any individuals entities in connection with recruitment with any GlaxoSmithKline or GSK group company at any worldwide location Even if they claim that the money is refundable If you come across unsolicited email from email addresses not ending in gsk com or job advertisements which state that you should contact an email address that does not end in gsk com you should disregard the same and inform us by emailing askus gsk com so that we can confirm to you if the job is genuine



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