Job Description

Key Responsibilities :1.Scientific/Medical Knowledge PV ExpertisePractical experience in and basic and emerging additional knowledge of pharmacovigilance and safety surveillance.Able to work more independently with limited supervision as required.May be assigned as responsible for safety monitoring and evaluation of assigned GSK products.Performs routine PV activities to include the review of ICSRs and monitoring and evaluation of assigned GSK products.Review literature articles for Safety topics of interest and detection of safety signals.Basic labelling knowledge and may participate in labelling team activities.Draft Aggregate Report safety sections and support addressing response to queries (RTQs).Perform Quality assurance of SERM deliverables - capable of management monitoring activities.Support LOCs to respond to local regulatory requirements.Support senior colleagues in process improvement initiatives within the global safety.2.Cross-functional Matrix team leadershipProficient understanding of a matrix team and matrix team requirements.Self-awareness of impact on others in matrix teams; respectful and being receptive to feedback on self.Capable of assisting senior colleagues in preparation for and presentations in matrix team meetings. May prepare for and present in matrix team meetings.Contributes to the activities of Safety Review Teams.Mentoring of junior SERM colleagues, can contribute to evaluating the activities of junior colleagues. Can explain knowledge and skills, and work in new situations."Builds working relationships and responds to the needs of line functions in the matrix in relation to safety issues.3.Communications (verbal, written) and Influencing (internal PV Governance and External LTs)Proficient writing and verbal communication skills - demonstrates clear and effective oral and written communication skills. can communicate ideas in business forums such as local and global team meetings. Can engage others in discussion points.Keeps manager/supervisor informed of progress and activities and escalates issues appropriately.Proactive communication e.g. active communication of ideas supports decision-making through provision of relevant information. Early capability to support a safety risk position. Growing confidence in communicating through multiple channels.Education Requirements : Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D). Advanced degree preferred.Job Related Experience Requirements:Exposure to pharmacovigilance or drug development.Minimum 7-12yrs of Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activitiesKnowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.Experience working in large matrix organizationsWhy GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 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, it\xe2\x80\x99s 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 \xe2\x80\x93 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. 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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 \xe2\x80\x9cgsk.com\xe2\x80\x9d, 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.

GlaxoSmithKline