Site Name: Belgium-Wavre, Bengaluru Luxor North Tower, GSK House
Posted Date: May 11 2023

Team Lead - Medical/Scientific Director (Safety, Evaluation & Risk Management) - Vaccines

This is a highly visible, global leadership role that allows you to lead a team and to have overall responsibility for determining the safety profile of approximately 15% of GSK vaccine products ensuring commitment to quantitative and qualitative safety compliance with items like DSUR/PSUR/PBRER, RMPs/BRMPs and medical review process. The role: The primary objective of the SERM Team Leader (TL) is to lead the surveillance of the safety profiles of a group of GSK vaccines, both under development and marketed, within his/her team by taking responsibility for the efficient and appropriate evaluation and aggregate review and reporting of all adverse events and at risk reports received by GSK vaccines. The TL has management responsibility for all members of a team of scientific and medical staff within the SERM, wherever they may be sited (global virtual team management). This is an above country function. Each team is expected to range in size from 5 (at present) to potentially 10 people. Each TL will manage all safety aspects within its portfolio during all phases of development and commercialization. Key responsibilities:

• Line management responsibilities for staff in their teams.
• Delegated accountability for ensuring team manages safety of allocated vaccine products according to relevant PV regulations and processes.
• Aids team members with decision-making, work prioritization and proactive pharmacovigilance.
• Ensures timely production of key deliverables for team: e.g. signal detection & evaluation; regulatory enquiries; product quality issues/PIRCs; periodic reports & renewals; label creation & maintenance; benefit risk assessment; due diligence activities and Safety Data Exchange Agreement (SDEA) input; risk management activities as appropriate to allocated products and as issues arise; documentation to VSMB/GSB when issues arises
• Responsible for training of team members particularly ensuring training of new starters in SERM processes and tools.
• Identifying areas of development for their team members and supporting them in their professional development.
• Promotes pragmatic, flexible, focused approach to workload.
• Delivers to key customer groups, as relevant to allocated products.
• May deputize for the SERM Head.
• May lead process initiatives and new innovation in PV methodologies.

Why You? Basic Qualifications:

• Biomedical sciences or Life Sciences related degree.
• Minimum 5+ years? experience in pharmacovigilance.
• Previous managerial experience.
• Detailed understanding of pharmacovigilance regulations and methodologies with respect to Central Safety Department (CSD) processes.

Preferred Qualifications:

• Higher degree (e.g. MD, PhD, MBA, MSc, MPH) or specialization.
• Highly effective communication skills.
• In depth understanding of the products for which the role-holder is responsible.
• Comprehensive knowledge of current regulations governing the processing and reporting of safety data (both internal to GSK Bio, GSK and external regulations).
• Hands-on understanding of the use of safety databases for adverse event evaluation and reporting.
• Leadership skills appropriate for managing a small-medium multidisciplinary team ? ability to build & motivate team, mentor, coach, and develop individuals.
• Ability to adjust behaviours and priorities based on changing environment and work flexibly in partnership with partner Team Leader(s).
• Demonstrated track record of quality decision making and creative problem resolution in critical situations, demonstrates balanced judgement.
• Relationship building with key stakeholders.
• Pragmatic approach.
• Looking for ways to make processes more efficient.
• Working to targets/achieving metrics.
• Demonstrated ability to think tactically and strategically and take account of internal/external environment.
• Ability to engage in, and contribute to, broad GSK environment and pharmacovigilance environment outside GSK with confidence, impact, integrity and professionalism.

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 positively impact the health of 2.5 billion people by the end of 2030. 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.