Sr. PVASC Specialist III at GSK

, , India -

Full Time

Start Date

Immediate

Expiry Date

29 Apr, 26

Salary

0.0

Posted On

29 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Safety Case Processing, Safety Evaluation, Adverse Event Reporting, Pharmacovigilance Database Maintenance, Quality Assurance Assessments, Regulatory Compliance, EDMS, Data Analysis, Document Archiving, Regulatory Inspection Representation, SOP Maintenance, Stakeholder Management, AI/ML Incorporation, MedDRA Coding, PowerBI, Organizational Skills

Industry

Pharmaceutical Manufacturing

Description

Business Introduction: At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Position Summary: You will lead safety case processing and support safety evaluation activities that keep patients safe. You will work with cross-functional teams across India and globally to ensure timely and accurate safety data handling. We value clear thinkers who act with integrity and care for patient outcomes. This role offers visible impact, strong learning opportunities, and the chance to grow within a global safety organisation that unites science, technology and talent to get ahead of disease together. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Expert in monitoring compliance by GSK and Third Parties with PVASC by carrying out routine HSI reconciliation, compliance checks and communicating standard information to Third Parties as required with appropriate guidance. Expert in monitoring compliance with regulatory and internal quality of global adverse event reporting. This can include performing Quality Assurance assessments of adverse event reports entered in the GSK global safety database. Role will work independently on this task, identifying and escalating findings and issues as required. Proficient in maintenance of information in the pharmacovigilance database, Electronic Data Management System (EDMS), PVASC website pages and shared areas including routine maintenance and documenting information as requested. Expert in collection, evaluation, analysis, and documentation of information received from local operating company safety departments. Expert in running standard listings from databases as required. Expert to administer document storage and archiving including team site per the approved processes. Represents during both external regulatory inspection and GSK audits of licensing partners with supervision from senior staff. Provides inputs, to and maintain guidance documents and SOPs. Can interact with colleagues in SERMs, Business Development, Operating Companies, and external companies as necessary with minimum supervision from senior staff. Contributions/leads projects relating to improvements in processes and systems e.g., EDMS with supervisions from senior staff. Performs other duties as assigned with supervisions from senior staff. Basic Qualification: We are seeking professionals with the following required skills and qualifications to help us achieve our goals Bachelor’s degree in life sciences, pharmacy, medicine, nursing, or a related health science. 5 - 9 years of pharmacovigilance or drug safety experience, including ICSR processing. Practical knowledge of pharmacovigilance regulations, Good Pharmacovigilance Practices, and clinical safety documentation. Experience with safety databases and electronic case processing systems. Strong medical terminology knowledge and experience with medical coding (e.g., MedDRA). Excellent computer skills including Word, Excel, PowerPoint, and SharePoint. Proficient in data visualization tools like PowerBI. Proficient in incorporating AI/ML into everyday ways of working. Ability to work independently with tight deadlines while under pressure; demonstrates planning and organizational skills. Results driven with a sense of urgency that ensures timelines within personal control are met. Good judgement, common sense, and pragmatism. Functions as a team player. Ability to work independently. Able to build and maintain relationships outside of functional area. Proactive problem identification. Bridges personal, business, and cultural differences to work effectively in team settings. Proficient in stakeholder management and customer focus. What we value in you We look for people who act with integrity, communicate clearly, and put patient safety first. We welcome different perspectives and foster inclusion. You will be supported to learn and develop while making a meaningful contribution to global safety activities. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. 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 IN.recruitment-adjustments@gsk.com to discuss your needs. 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. We are 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. Find out more on our career site.

Responsibilities

This role involves leading safety case processing and supporting safety evaluation activities to ensure patient safety, working with cross-functional teams globally for timely and accurate safety data handling. Responsibilities include monitoring compliance with PVASC regulations, performing quality assurance assessments of adverse event reports, and maintaining pharmacovigilance database information.