Medical Director SERM, Open to flexible working
Job Description Summary-Job Family - Safety/ Pharmacovigilance:
Responsible for the company's drug surveillance program including the necessary follow-up, assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. May provide trending and safety signal detection and risk management assessment for the products' life cycle. Some of these roles will require qualification as a health professional Job Family Group - Medical and Clinical: Evaluates the efficacy and safety of drugs in human clinical studies. (Phases I to IV) involving patient interaction and/or research, consulting, bench work and/or analysis. Provides medical expertise to ensure the proper development of new products and the optimal positioning and promotion of existing products.
Are you energised by the opportunity to work with global stakeholders to design, deliver and embed critical highly visible safety programs that have a global impact? If so, this Safety Pharmacovigilance Director role could be an ideal opportunity to explore.
As a Safety Pharmacovigilance Director, you will play a key role in supporting the Central Safety Leadership Team, and the broader business at both a strategic and operational level.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
Deliver strategic solutions and lead the implementation for key organisational/process changes ensuring that GSK can comply with pharmacovigilance regulations worldwide Develop strategy and lead the implementation of core business activities (e.g. Communications, Information Management, Training), seeking endorsement from the Central Safety Leadership team; provide ongoing, thoughtful program management and change management support to ensure delivery against a strategic agenda
Lead the review and re-design of critical business processes; deliver solutions that align across business units; develop and lead training / change management activities
Provide specific subject matter expertise on relevant business processes to ensure regulatory compliance and appropriate management of risk across GSK (to include authoring process documents, adhering with evolving regulatory requirements, delivery of training and the proactive identification of potential compliance risks) Secretariat to Central Safety governance boards/leadership teams as appropriate; ensure appropriate/timely agendas/minutes (to include action tracking) based on input from stakeholders; provision of appropriate project management leadership
Project management support for the business change initiatives/process updates to include driving the development and tracking of business plans (including objective setting, Key performance Indicators, benefits tracking)
Line manage scientific/technical associate staff who support specific business activities including provision of metrics, information management, communication and website related deliverables (as needed)
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree
- Prior experience managing multiple strategy formulation and change projects
- Experience with Pharmacovigilance processes and global Pharmacovigilance regulations
If you have the following characteristics, it would be a plus:
- Advanced Degree Life Sciences or Pharmacovigilance
- Professional certification in Project management
- Ability to effectively influence key stakeholders at all levels of the organisation
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.
You may apply for this position online by selecting the Apply now button.
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