Job Description

Are you looking for a high-profile safety role that ensures the accuracy of critical safety data across multiple geographies? If so, this Safety Pharmacovigilance Manager role could be an ideal opportunity to explore.As a Safety Pharmacovigilance Manager, you will manage the set-up, handover, and oversight of the Pharmacovigilance (PV) Hubxe2x80x99s various country requirements, ensuring high PV standards and following regulatory mandated requirements across designated country clusters. You will be responsible to ensure there is close alignment with respective General Managers (GMs) to ensure governance requirements.This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:Responsible for day to day management of Adverse Event (AE), incident and pregnancy reports for all countries within the Hub.Accountable for exchange of safety data with licensing partners and maintenance of report files for local Safety Data Exchange (SDE) agreements as necessary.Responsible for fulfilling local regulation for reporting to local regulatory authorities within mandated timeframes for expedited reports.Ensure relevant training to authorized external third parties and internal stakeholders on literature review purposes, adverse event reporting, and medical information queries.Notify CSD of any new GSK sponsored external facing websites that include free text facility.Ensure a process is in place to identify and process AEs from websites including additional responsibility for medical information processes within the assigned country clusters.Monitor locally published medical and scientific literature to identify reports which may not have been indexed on commercial or internal literature databases and for documenting the local literature review monthly.Ensure there is an established process for liaison with the relevant departments dealing with product complaints and medical enquiries (in all countries).Regular review of local product complaint log to ensure that AE, incident or pregnancy information reported in association with a product complaint or medical enquiry is notified to the Named Safety Contact (NSC).Escalate issues to the relevant GSK CSD and Manufacturing Site Complaints Coordinator (in all countries).Day to day management of AE, incident and pregnancy reports in GSK sponsored clinical studies within specific timeframes.Notify the appropriate legal department and Head of the relevant CSD of any potential or actual legal action or liability with respect to human safety.Responsible for governance of the Pharmacovigilance/Medical Information operations within designated clusters and coordination of central requests.Serve as Internal GSK reference point of contact for Local Operating Companies (LOCs)/Rep Offices/Do Not Promote (DNP)/Direct to Government (DTG) and central teams.Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:PharmD (Pharmacists degree)2 or more years of experience working in the pharmaceutical industryExperience in Pharmacovigilance and Medical Information regulatory requirements, systems, and processesExperience with medical governance across multiple geographiesPreferred Qualifications:If you have the following characteristics, it would be a plus:Doctor of Medicine (MD)Strong collaboration, planning, execution, and communication skillsAbility to influence across a highly-matrixed organizationWhy GSK?Our 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 xe2x80x93 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-beingBuilding strong relationships and collaboration, honest and open conversations.Budgeting and cost-consciousnessWhy GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose xe2x80x93 to unite science, technology and talent to get ahead of disease together xe2x80x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns xe2x80x93 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, itxe2x80x99s 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 xe2x80x93 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 xe2x80x9cgsk.comxe2x80x9d, 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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