Posted Date: Jul 30 2020
Are you a safety/pharmacovigilance physician with in-depth and hands-on experience? Do you want to work on the development and introduction of a new medicine that will have global impact? Do you want to work with high-profile partners like the World Health Organisation, Bill and Melinda Gates Foundation and the US Centre for Disease Control and Prevention?If you've answered yes to all 3 questions, don't miss out on this fantastic opportunity!
You will provide high level medical expertise in the safety evaluation and risk management of a new antimalarial medicine 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
We expect you to have a proven ability to lead safety evaluation activities, ensuring that appropriate safety objectives and risk minimisation strategies are included in clinical development programmes.We also expect you to be able to influence at all levels of the organisation using your experience, confidence and credibility.
- Safety Governance and Risk Management activities
- Signal Detection, Evaluation and Labelling
- Regulatory Reports and Submission
- Presents the disease area or product area safety strategy at key internal GSK meetings and represents GSK externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners.
- Accountable for medical review and sign-off for regulatory documents, including periodic safety update reports (PSURs)
- Other SERM Activities including driving the review or production of the SERM component of Safety Data Exchange Agreements; participating in due diligence activities; providing support to GSK Legal for product liability litigation; providing input to, or participating in, meetings of an independent data monitoring committee (IDMC) or GSK internal safety review committee (iSRC), etc.
We are looking for professionals with these required skills to achieve our goals:
- Medical Degree, ideally GMC qualified
- Expert evaluation skills and analytical thinking
- Outstanding medical writing skills
- Sound computing skills
- 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
- Sound knowledge of the therapeutic area of assigned GSK products
- Sound knowledge of other related disciplines, e.g. statistics, epidemiology relevant to assessing drug utilization 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
- Clear understanding of clinical development process
- Clear understanding of drug approval process in major countries
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
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
This is a job description to aide in the job posting, but does not include all job evaluation details.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.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 race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/e
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