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Report Specialist & Vigilance Intelligence Owner, Global Safety Surveillance & Analysis (m/f)
Egham, United Kingdom
Are you interested in innovating and making a difference while working for a global company? As an engineer in R&D, you will be involved in all stages of the design process, from conception to presentation of the finished plans. You will constantly be learning, growing, and improving as you find new ways to innovate and develop within your area.
- Full Time
- Level: Recent Grad/Entry level
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Job Title and Business Purpose
Report Specialist & Vigilance Intelligence Owner, Global Safety Surveillance & Analysis
Are you passionate about the science behind products? Do you want to develop innovations for the world's biggest brands? Then a technical career at P&G could be what you're looking for!
Every year we invest around $2 billion in Research & Development (R&D), corresponding to more than 2% of company net sales. Our R&D teams are the inventors who invent and improve products loved by customers in hundreds of countries around the globe. We’re talking state of the art technology, “hands-on” labs and pilot plants, 41,000+ active patents and a team full of inventors.
GSSA is part of the Global Product Stewardship function within Research & Development. We are responsible for consumer safety and global compliance. We work with the Human Safety function to provide continuous safety support throughout the life of a product. Specifically, GSSA delivers post-market safety support by establishing and maintaining the global systems and work practices necessary to ensure compliance with current safety surveillance regulations. This work includes monitoring post-market safety through individual and aggregate analysis of adverse event data, signal detection and signal management practices.
As a Report Specialist, you will be responsible for ensuring that the processes necessary to deliver safety surveillance reporting in a region are in place and sufficient. You will also serve as a regional contact for adverse event regulatory reporting for GSSA.
As a Vigilance Intelligence Owner, you will establish and maintain a robust understanding of post-market safety surveillance regulatory requirements. You will collaborate within GSSA to ensure that our procedures and work processes are compliant with all applicable regulations.
Your normal place of work will initially be the Greater London Innovation Centre in Egham but is expected to move to the Greater London Innovation Centre in Reading.
We are looking for a highly motivated, skilled and agile individual to do this role. Your key responsibilities would include:
- Notification of potentially reportable adverse event reports to key P&G personnel. Timely reporting of all relevant adverse events to appropriate Regulatory Authorities. Submission and archiving of regional periodic regulatory reports.
- Identification of post-market legislation, guidance and other requirements in countries where P&G products are marketed. Maintenance of close links with P&G contacts in the countries to develop expertise in post-market safety surveillance regulatory interpretation and influencing. Monitor regulatory changes affecting GSSA.
- Perform assessments for every adverse event that comes in for a cosmetic product in Europe. Timely preparation of Safety Data Summary Sheets. Reporting of Serious Undesirable Effects to the appropriate local Regulatory Authority.
- You will need to be a motivated individual, ideally with a life sciences background. Experience with safety surveillance or another compliance-related role (e.g. Regulatory Affairs, Quality Assurance) would be of use but is not essential.
- We are looking for candidates who are thorough and detail-oriented with a real drive to be complete and accurate in their work. This is because the work you will do is critical to ensure ongoing compliance with regulatory requirements.
- Excellent written and oral communication skills, especially in communicating scientific information are essential. Experience with external communications (regulatory authorities, industry groups) would be of use but is not essential. An aptitude for systems in general and experience with electronic data capture systems is desirable.
- We are looking for those who can build and maintain diverse and collaborative relationships. GSSA partners with multiple functions within P&G globally, often virtually. You must therefore have the ability to build and nurture collaborations with key P&G functions.
- You must be able to operate with both discipline and flexibility. GSSA is a dynamic and fast-moving organization and so you will need to be agile and able to focus on priorities and execute against them.
What we offer you
- Responsibilities as of day 1. You will have full ownership and autonomy to deliver change and results from the beginning.
- Dynamic and respectful work environment. At P&G our employees are at the core, we value every individual and encourage initiatives, promoting agility and work/life balance.
- Continuous coaching. You will work with passionate people and receive ongoing coaching and mentoring from your line manager and other colleagues. Corporate and functional training will enable you to succeed and develop from day one.
- Benefits. You will receive a competitive salary as well as other great benefits including pension & share schemes.
- Good to know
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, disability status, age, sexual orientation, gender identity and expression, marital status, citizenship or any other legally protected factor.
Location: Egham, United Kingdom
Job Id: RND00003842
Paid Time Off
Health and Wellness Programs
Stock Purchase Program
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