Pharmacovigilance Safety Scientist, Manager
- Brentford, United Kingdom
Site Name: UK - London - Brentford
Posted Date: May 12 2020
An exciting opportunity has arisen for a Manager, CH Safety Evaluation and Risk Management to join GSK's Consumer Healthcare Safety Evaluation and Risk Management (SERM) group to be responsible for the continued safety assessment, evaluation and risk management of major GSK products in the post-marketing setting. GSK's Consumer Healthcare business develops and markets brands in the Oral Health, Pain Relief, Wellness and Respiratory & Skin Health categories. We are one of the world's leading Over the Counter healthcare companies and our strategy is to meet the everyday healthcare needs of our consumers through building consumer preferred and expert recommended brands, differentiated by science and insight driven innovation.
- In conjunction with the safety physician, performs routine signal detection activities (literature review, tools for individual case awareness and aggregate data review) in order to identify, assess and escalate signals appropriately.
- Conducts, or leads with guidance, the discussion and management of safety issues through matrix teams across the global organisation and the presentation of findings to GSK governance bodies.
- Authors regulatory documents (e.g. PSURs, renewal documents, risk management plans, submission documents) according to the agreed process and timelines.
- Contributes to labelling updates by preparing documentation and presenting to relevant boards.
- Participates in project focused meetings and provides safety expertise along with safety physician
- Contributes to advancement of methodology and process within SERM by generating new ideas and proposals for implementation
Why you? Basic Qualifications:
- Bsc Biomedical Science / Pharmacy degree (or equivalent), or above.
- Background in pharmacovigilance or other relevant field
- Experience in Signal Detection
- Experience in authoring periodic reports eg. PSURs, DSURs, renewals documents and Risk Management Plans
- An awareness of international pharmacovigilance requirements (e.g. ICH, EU pharmacovigilance regulations, FDA and CIOMS initiatives) and the drug development and approval process in major countries
- Experience with consumer healthcare products eg. medicinals, cosmetics, devices and nutritional supplements
- Attention to detail and the ability to work effectively in a dynamic environment characterised by tight timelines and changing priorities.
- Highly effective oral and written communication skills.
- Effective negotiating, influencing and persuasion skills.
- Knowledge of other relevant disciplines (e.g. statistics, pharmacoepidemiology) pertinent to safety at the population level.
- MHRA experience
Our values and expectationsare 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:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being .
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
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/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.
Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email email@example.com
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