Safety Scientist (Director)
Site Name: USA - Pennsylvania - Philadelphia, USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Upper Providence Posted Date: Sep 30 2021 This role can be based from either a home office in the US, or from the GSK sites at RTP (North Carolina) or Upper Providence (Pennsylvania). As a member of the SERM (Safety Evaluation and Risk Management) group at GSK, you will provide key safety leadership and expertise to the Oncology portfolio. This will span from clinical development right through to marketed products, offering a true breadth of experience in safety. Through signal detection, signal evaluation, data review and other pharmacovigilance tasks, you will ensure all safety information is efficiently evaluated in keeping with global compliance end regulatory requirements. You will identify need for updates in labelling and drive other proactive changes to enhance risk management. We need someone who can be a real safety leader in this role. You won't just be gathering data, but will need to interpret and understand key safety information, translating this into positive or remedial actions which drive safety objectives and risk mitigation, as well as promoting a positive and progressive safety culture - including influencing and engaging with partners in a range of functions within the business. Due to the size of our oncology portfolio, this position will offer considerable exposure to the drug product lifecycle and a real variety of product, including immuno-oncology drugs. You will be part of a complex, matrixed organisation full of passionate, motivated and committed safety experts - individuals you can learn from, share with and support in your own right. This is a team that works in an extremely collaborative way, guaranteeing variety, flexibility and opportunity for the successful candidate. Key Responsibilities include, but are not limited to: Significant contribution to safety, pharmacovigilance and risk management activities for the Oncology portfolio Participation in cross functional, matrixed teams, in which you play a safety leadership role Providing technical input, review and approval to a range of key documents and processes, including presenting safety information during clinical and commercial meetings Drives and conducts signal detection within Oncology, subsequently leading assessment of safety data, results and potential recommendations Producing accurate and appropriate documentation to support regulatory filings and other investigations Playing a positive role in the production and submission of high-quality regulatory documents, including supporting LOC's with license renewal documentation and more Contributing expert safety knowledge to a range of due diligence activities, internal assessments and audits etc. Leading process improvement initiatives within SERM which contribute to advancements in methodology and process through new ideas, new implementations, continuous improvements and more As a leader, contribution to the training, coaching and mentoring of others in signal evaluation, risk management and safety, acting as an exemplar of safety and risk management practices About You: The SERM team is a highly collaborative and matrixed organisation, which works in partnership with the wider business. As such, the successful candidate will need excellent communication and team working skills and must be comfortable with influencing and negotiate at all levels. This will also require flexibility and adaptability, adjusting behaviours to meet the current need. You must be able to make quality decisions and resolve problems while dealing with complex information, absorbing and evaluating considerable data to do so. It's also important that you are comfortable with multi-tasking and prioritising, as well as dropping in and out of projects at short notice in order to best support the safety needs of the wider team. This is a group that works best as a whole, so sharing and helping one another is crucial to this success. As a leader in safety, you'll also need to be comfortable with training, coaching and mentoring. You'll set a positive example, whilst also helping to delegate and coordinate tasks, projects etc. Within these projects you'll need to be credible and effective, contributing impactful and innovative ideas which support tactical and strategic improvements with both a safety and a commercial business perspective. CLOSING DATE for applications: October 30th (COB) Please take a copy of the Job Description, as this will not be available post closure of the advert. Why You? Required Qualifications and experience: Qualified as a PharmD, Pharmacist, Nurse, Nurse Practitioner or other formal education in Biomedical or Health Care specialism 5 years' experience in a Safety / Pharmacovigilance position 10 years' experience in Pharma industry Experience in Medical writing Experience analysing safety data to drive solutions Experience of pharmacology Experience of the clinical development and approval process Preferred Qualifications and experience: Oncology Drug Development experience Experience of marketed/commercial products in Oncology or Immunology Experience in statistics and epidemiology Why GSK? GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. 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