Medical Director SERM
Site Name: Collegeville TSA, USA - Pennsylvania - Upper Providence Posted Date: Mar 30 2021 Are you looking for an exciting opportunity to make an impact as a physician safety lead across multiple programmes, leading the safety strategy for assets across immuno-oncology, cell and gene therapy and other specialty therapy areas? We are seeking a highly motivated individual to join GSK as a pharmacovigilance / safety physician in our Global Safety Department. This is a fantastic opportunity to utilise your pharmacovigilance knowledge and experience, and to be the SERM director/ Safety Lead for a number of assets As the SERM Oncology Medical Director, you will provide high level medical expertise in the safety evaluation and risk management of new and cutting-edge immuno-oncology medicines in clinical development and/or the post-marketing setting. You will ensure that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements, identify the need for product labelling updates and drive proactive implementation of risk management initiatives. You will have a proven ability to lead safety evaluation activities, ensuring that appropriate safety objectives and risk minimisation strategies are included in clinical development programmes. You will influence at all levels of the organisation using your experience, confidence and credibility, and represent the disease area or product area safety strategy at key internal GSK meetings and externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners. Additionally, you will be accountable for medical review and sign-off for regulatory documents, including periodic safety update reports (PSURs). This role will span the work of project and product safety as practiced by physicians in both the GCSP SERM: Development and GCSP SERM: Mature Products groups. Global Clinical Safety & Pharmacovigilance (GCSP) is responsible for the collection, processing and regulatory reporting of adverse events experienced by patients receiving GSK products and for the ongoing safety evaluation and risk management of all GSK products (marketed or developmental). This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: - Medical Degree, specialisation in oncology, critical care or intensive care medicine preferred - Expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities - Expertise in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labelling changes, physician and patient education. Likely to be recognised as an authority in this area at high levels both within GSK and possibly in the external international pharmacovigilance arena - Expert evaluation skills and analytical thinking - In depth knowledge of other related disciplines, e.g. statistics, epidemiology relevant to assessing drug utilisation and safety at the population level - In depth knowledge of medical and drug terminology and a sound foundation in pharmacology. Good medical judgement and ability to make medical decisions - In depth knowledge of clinical development process - In depth understanding of drug approval process in major countries - Outstanding medical writing skills - Sound computing skills Preferred Qualifications: As above Location: There is flexibility for the ideal candidate to work at any of the following locations : Upper Providence, Collegeville, PA and Waltham, MA Why 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: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox. Managing individual performance. Creating a performance culture and driving results, prioritisation, execution, delivering performance. Setting strategic direction and leading on-going organisational transformation. Building a resilient organisation. Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit. Managing P&L and capital allocation. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). 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