Principal Scientist, Pv Operations

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 Hubs 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 youBasic 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 GSKOur 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 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 GSKUniting 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 its 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 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 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