Director, Pharmacovigilance & Drug Safety
- Brentford, United Kingdom
Site Name: UK - London - Brentford
Posted Date: Jun 19 2020
The new Consumer Health Business in GSK is a fastmoving dynamic business, bringing together, as part of a joint venture with Pfizer, two exciting consumer-centric portfolios which include Oral Health, Respiratory & Skin, Pain and Wellness. As the Safety Evaluation and Risk Management Director, you will provide high level scientific expertise in the safety evaluation and risk management of key GSK Consumer Health products. You will ensure that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements, identifying the need for product labelling updates and driving proactive implementation of risk management initiatives. In addition, you will provide highly proficient safety expertise as part of cross-functional innovation teams, helping GSK to ensure that new product developments consider consumer safety as a primary objective.
A role in GSK Consumer Health offers the opportunity to work across a portfolio with true variety, with products including medicines, devices and cosmetics. As part of the joint venture, this portfolio is becoming even stronger, including a variety of well-known and instantly recognisable products. This is an area of the GSK business which is highly innovation driven, offering it's employees a consistent, fast-paced challenge and the chance to work with many other areas of the wider business, both locally and internationally, to help safely drive and maintain GSK's Consumer Health business.
Excellence in this role will be about much more than technical knowledge. You will need that scientific expertise, but must marry it with the high level inter-personal skills required to enact changes and to flourish at this level, as you will be a senior representative of Safety, interacting with a large cross-functional group. You will need to be an effective communicator, able to present complex data to groups at all levels of the organisation, as well as parties external to GSK. You'll have highly developer negotiation and influencing skills, setting appropriate expectations, creating engaged and effective relationships, and knowing when to put your foot down. Safety is critical, and you will ensure it is prioritised across the business and that others involved understand the safety perspective and it's importance.
You will manage multiple projects and tasks simultaneously, so the ability to balance these, and to delegate to project teams is critical, all whilst maintaining effective delivery and quality levels. You will work well to deadlines, but know when compromise is not an option, and will actively seek and identify opportunities for improvements in safety and business process.
- Performs proactive signal detection for assigned products using available methodologies, including individual case review, literature review and tools for disproportionality analysis.
- Produces accurate and fit for purpose evaluation documents with clear conclusions and recommendations, in response to internal or regulatory authority requests for safety data.
- Accountable for safety input into regulatory benefit risk assessments, periodic reports and renewal documents.
- Represents Consumer Health Safety and leads safety discussions on cross functional matrix teams and/or project teams, to ensure appropriate consumer safety consideration for development of new consumer products.
- Recognises and escalates appropriate safety issues to Governance Boards.
- Provides safety expertise for license partner agreements and due diligence activities.
- Drives complex process improvement initiatives within and across the safety organisation.
- Trains, coaches and mentors junior staff.
Essential qualifications and skills:
- Degree in Biomedical or Health Care related speciality eg. Pharmacy
- Significant experience working experience in Pharmacovigilance and drug safety
- Expert product safety evaluation skills and analytical thinking
- Expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to Safety evaluation activities
- Expertise in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labelling changes, physician and patient education.
- Higher degree or PV qualification
- Knowledge of Consumer Heath environment including legislative requirements
- Project Management skills
- Ability to provide innovative ideas to address new issues or improve approaches to existing operations with demonstrated ability to take a lead in driving needed change
- Ability to adjust behaviours and priorities based on changing environment
- Demonstrated ability to think tactically and strategically and take account of internal/external environment when considering safety issues and business processes
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:
- 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.
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.
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