Job Description

Site Name: Bengaluru Luxor North Tower
Posted Date: Sep 14 2022
Our patients deserve bold, ambitious ideas 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. Job Purpose:-

• Responsible for the continued safety monitoring and evaluation of assigned GSK products in the post-marketing setting in Safety Evaluation and Risk Management (SERM) department.
• Ensures that adverse events and other safety information is efficiently evaluated and that safety reports are completed accurately and in a timely manner to meet global compliance and regulatory requirements.
• Provides safety input on cross-functional teams.
• Responsible for maintenance of labelling for assigned GSK products.

Key Responsibilities:- Signal Detection and Evaluation

• Runs routine signal detection process, including review of individual case reports via Case Awareness Tool, literature review, On-Line Signal Management Tool, in partnership with SERM physician, for all products in area of responsibility.
• Discusses need for, and priority of safety related findings/ signal reviews with the SERM Team Leader/ SERM physician; communicates, escalates and documents the outcome of signal detection process.
• Identifies and uses appropriate sources of information and database searches to retrieve relevant data for evaluation of signals. Proactively proposes data evaluation methods and discusses the results with the SERM Team Leader/product physician and other stakeholders.
• Produces accurate and fit for purpose exploratory/ evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data, in consultation with relevant stakeholders, as necessary.
• Routinely monitors safety issues potentially related to a product defect and/or manufacturing issue; communicates with the SERM physician/ SERM Team Leader and/or Manufacturing; documents outcome.

Aggregate Reports and other Regulatory Submissions

• Authors periodic regulatory documents (PBRERs) according to the agreed process and timelines.
• Supports the Local Operating Companies by preparing license renewal documentation (e.g. Addendum Reports, Line listings, Clinical Overviews), as required for each market.
• Authors the SERM safety contribution to other global regulatory submissions or answers to safety-related questions from Regulatory Agencies, in cooperation with relevant functional experts.

Risk Management activities

• Authors global Risk Management Plans/ regional Risk Management Plans for designated products, in consultation with senior colleagues.
• May contribute to Regulatory Benefit-Risk Assessments requiring safety team input.

Labelling

• Creates and maintains of the Global Product Information (PI) for products supported.
• Produces regulatory supporting documentation for labelling updates.
• Provides recommendations for labelling changes for Single Market Products, as applicable.
• Provides answers to Regulatory Enquiries related to labelling content.
• Provides relevant input into regulatory requests for local label deviations from the Reference Safety Information, in cooperation with relevant Functional Experts (Country Labelling Difference Process).

Other SERM Activities

• May review Safety Data Exchange Agreements, and escalates any deficiencies to the SERM Team Leader to ensure quality and integrity of agreement
• May conduct review of list of studies, and identifies TSS/ PASS status. Ensures prompt notification to SERM Team Leader of any studies that are identified as potential PASS.
• Accountable for maintaining personal readiness in response to internal audit or regulatory inspection.
• Participates in process improvement initiatives/ workstreams in Global Safety Department.
• Raises concerns/ issues to senior management in a timely, open and appropriate manner; ensures quality and integrity of issue/event being escalated.
• May mentor and train more junior scientists in own area of expertise e.g. signal evaluation methodology, risk management and/or preparation of safety reports and other documents.

Expected competencies for this role:

• Good functional knowledge and expertise, developing confidence to work independently with minimal supervision for executing the safety activities including but not limited to data generation & gathering, data analysis & interpretation, prioritisation of tasks.
• Some autonomy with some supervision required.
• Ability to showcase developing confidence in making challenging decisions.
• Makes decisions based on facts, common sense, previous experience; weigh up the pros and cons; and be able to explain the reasoning behind decisions.
• Demonstrates clear and effective oral and written communication skills.
• Growing confidence in communicating through multiple channels.
• Develops and presents persuasive arguments that enlist support and address the concerns, wants, and needs of others.

Knowledge/ Education / Previous Experience Required:- 1. Minimum Level of Education - A university degree in Health Sciences or related disciplines 2. Preferred Level of Education - Master’s degree or higher in Health Sciences Area of Specialization - Medicine, Pharmacy, Biology, Biotechnology or related disciplines. Minimum Level of Job-Related Experience required :-

• 7 to 11 years of relevant experience
• Fluent English and communication skills
• Strong medical/ scientific writing skills.
• Basic computing skills (to common office applications and familiarity with safety databases). Good working knowledge of medical and drug terminology.
• Good working knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities.

At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

• LI-GSK

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. Important notice to Employment businesses/ Agencies GSK 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.