CMG Principal Scientist, Open to flexible working
GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to support our mission to improve the quality of human life by enabling people to do more, feel better and live longer.
The key purpose of this role is to ensure the safety of all GSK Clinical Trial participants and patients administered GSK products, by ensuring the successful collection, assessment and reporting of safety data (adverse events). This role ensures that case processing activities align with GSK standards for processing HSI and that regulatory timelines are achieved. This is done by managing case processing activities and overseeing the case processing vendor.
The successful candidate will ensure relevant Alliance-related oversight to the Case Management Group (CMG) Directors and drives the understanding of adverse event collection requirements across all business units. Apply to learn more!
Key Responsibilities include, but are not limited to:
- Works across a complex matrix environment to drive high-quality delivery of case management activities that comply with internal standards and external regulatory requirements; where problems or issues are identified, facilitates investigation into root cause and creation of corrective/preventative actions (CAPAs).
- Communicates and works collaboratively with CMG Quality and Compliance to enhance quality of case processing activities.
- Acts as a point of contact for the vendor, for audits and inspections and contributes to CAPAs specific to case management activities.
- Contributes to all aspects of case handling activities from case receipt to expedited reporting and interactions with the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs), and clinical operations.
- Generates new ideas and proposals for global implementation; contributes to advancement of CMG methodology and processes.
- Ensures third parties/vendors develop and implement robust processes to support quality-driven organization.
- Reviews and maintains oversight of training materials developed by third parties/vendors.
- Accountable to build external relationships with key stakeholders to ensure successful delivery of outsourced work, demonstrating GSK values during interactions.
- Monitors key performance indicators (KPIs) generated from supplier and quality organizations, determines appropriate responses to manage and mitigate risk, and identifies issues for escalation/action as required.
- Maintains awareness of EMA/CRO/licensing partner reporting rules and ensures case handling is performed in alignment with reporting timelines and expectations; demonstrates expert working knowledge of the regulatory environment on a global level.
- Recommends system enhancements to improve case processing compliance and quality; supports innovation from idea to implementation.
- Supports Scientists with enhancement of knowledge and skills with regards to Alliance activities, where required.
- Identifies training needs; prepares, coordinates and delivers training to staff within CMG and departments outside of SMG; designs, produces and maintains the CMG core curricula (including TCS).
- Act as a global Case Management leader for process discussions, including queries on strategy/policy related decisions; authors or provides significant input to standard operating procedures (SOPs) and guidance documents.
Closing Date for Applications: 1st March 2021 (COB)
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
We are looking for professionals with these required skills to achieve our goals:
- Degree in life sciences or medically related field or previous experience equating to educational requirements.
- Knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP), clinical safety documentation, reporting of adverse events from clinical trials, local regulatory requirements, and pharmacovigilance methodology; general understanding of worldwide regulatory requirements.
- Working knowledge of principles of data collection, manipulation and retrieval and experience summarizing data.
- In-depth understanding of medical and drug terminology.
- Proven experience of Prioritisation and time management.
- Strong communication skills.
If you have the following characteristics, it would be a plus:
- Health care professional (e.g. pharmacist or nurse) preferred.
- In-depth knowledge of safety database strongly preferred.
- Knowledge of GSK products.
- Project management experience.
- Vendor management experience.
- Proven experience developing and delivering high-quality training.
- Experience of providing mentoring to other staff.
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:
- 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.
At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best.
When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it's about you being motivated to do your best work, in a place where you can be you, feel good and keep growing.
Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers.
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.
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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