Senior Safety Evaluation Scientist-Literature

Site Name: India - Karnataka - Bengaluru

Posted Date: Nov 19 2024

Experience: 8 to 10 Years

Location:: Bangalore

Key Responsibilities:

Ensure timely production of key deliverables by team, including but not limited to:

• Screening and reviewing literature search results (articles/abstracts/citations) for purposes of aggregate report inclusion and potential safety signal identification.
• Maintaining and documenting up-to-date product knowledge to aid in literature review.
• Balance resource requirements and promote a pragmatic, flexible, focused approach to workload.
• Ensure that direct reports have business objectives set, development plans in place and complete all trainings, as required.
• Develop and share pharmacovigilance and literature review knowledge and experience with team members.
• Ensure that discussions needed for, and priority of safety related findings/ signal reviews with the SERM product specialists / SERM physician, communications escalations and documentation of the outcome of signal detection process are done efficiently.
• Collect data on time, cost, quality, and compliance and ensures team meets targets for all measures including defined Key Performance Indicators (KPIs)
• Aid direct reports with decision-making, problem solving and work prioritization; provide management review and quality check support as required.
• Demonstrate expertise in quality checks for review of literature search results (articles/abstracts/citations) for purposes of aggregate report inclusion and potential safety signal identification evaluated by team members.
• Identify or participate in continuous process improvement activities related to area of responsibility or as requested
• Maintain good documentation practice and be the Point of Contact in case of inspection/audit
• Maintain appropriate organizational networks
• Demonstrate GSK values.
  
  
  

Education Requirements (minimum expected):

Bachelor’s Degree - Life sciences, Pharmacy, Medical or pharmacology degrees

Preferred: Master’s degree or higher in Health Sciences.

Job 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.
• Competent medical/ scientific writing skills.
• 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 web-based applications.
• High level of flexibility and ability to prioritize work.
  
  
  

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, it’s 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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