SERM Associate Scientific Director

Job title:

SERM Associate Scientific Director

Company

GlaxoSmithKline

Job description

SERM Associate Scientific Director provides medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting.SERM Associate Scientific Director ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. Makes recommendations for the further characterization, management, and communication of safety risks.Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.If appointed as a manager (i.e., Team/Group Leader) is responsible for leadership of a team of individual contributors. Line Management (including functional matrix reports) leadership competencies include resource and team management, coaching, influencing others, collaborative working, decision making, change management, partnership, and relations management.Key Responsibilities:Provides medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting.Ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. Makes recommendations for the further characterization, management, and communication of safety risks.Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.If appointed as a manager (i.e., Team/Group Leader) is responsible for leadership of a team of individual contributors. Line Management (including functional matrix reports) leadership competencies include resource and team management, coaching, influencing others, collaborative working, decision making, change management, partnership, and relations management.Key Responsibilities1.Scientific/Medical Knowledge PV ExpertiseResponsible for signal detection and evaluation activities for assigned products.Drives production of regulatory periodic reports and associated documentation and RMPs globally according to the agreed process and timelines; advises on content of regulatory period reports (in partnership with the product physician).Authors the SERM safety contribution to global regulatory submissions in partnership with the product physician.May respond to auditors/inspectors’ requests for information/additional information and completes corrective and preventative actions (CAPAs) within agreed timelines.Advanced evaluation skills and analytical thinking for literature review, data gathering, data synthesis, analysis and interpretation.Makes sound decisions based on relevant information or factors gathered from a broad range of sources, seeking help and input as needed. Identifies, evaluates, and recommends solutions to problems.Committed to the task and able to prioritise activities effectively and meet multiple deadlines successfully and with appropriate attention to detail, setting high performance standards for quality.2.Cross-functional Matrix team leadershipSupports and Facilitates safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.Leads or participates in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality, and efficiency.May author/participate in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently.Builds strong collaborative relationships and demonstrates good matrix leadership skills, proactively providing input to matrix teams on safety issues and processes. Ability to coach and mentor others.3.Communications (verbal, written) and Influencing (internal PV Governance and External LTs)Presents complex issues to senior staff members at the GSK Senior Governance Committees.Demonstrates initiative and creativity in performing tasks and responsibilities. Proactively contributes ideas to improve existing operations.Proactively contributes ideas to improve existing operations.Participates in process improvement initiatives within GCSP and contributes to advancement of methodology and process by generating new ideas and proposals for implementation.Possesses effective communication skills and is capable of presenting ideas and data clearly and concisely to a matrix team. Listens and responds appropriately to the views and feedback of others.Robust medical/scientific writing skills are essential, as the preparation of detailed evaluations and reports on major GSK products is a core feature of the role.Effective negotiation, influencing and persuasion to enable others in the matrix to understand own perspective.Skills and Qualifications:Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D). Advanced degree preferred.Substantial experience in pharmacovigilance or drug development.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 – 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, 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.As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on or 0808 234 4391.Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the and scroll to the Careers Section where you will find answers to multiple questions we receiveAs you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.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.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting site.

Expected salary

Location

United Kingdom

Job date

Sun, 18 Aug 2024 03:47:18 GMT

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