PSMF and QPPV Office Manager-2407022012W
Description
PSMF and QPPV Office Manager
This position reports to Qualified Person for Pharmacovigilance (QPPV) and is based at UK or Poland.
Who we are
At , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including Neutrogena, Aveeno, Tylenol, Listerine, Johnson’s and BAND-AID® Brand Adhesive Bandages that you already know and love.
Science is our passion; care is our talent. Our global team is made up of 22,000 diverse and brilliant people, passionate about insights, innovation and committed to delivering the best products to our customers.
With expertise and empathy, being a Kenvuer means having the power to impact the life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage and have brilliant opportunities waiting for you! Join us in shaping our future and yours.
For more information, .
Role reports to : Qualified Person for Pharmacovigilance (QPPV)
Location : the UK or Poland
Travel % : 0%
What you will do
The PSMF and QPPV Office Manager is responsible for is responsible for ensuring the day-to-day operations of the QPPV Office and EEA and UK PSMF delivery as per process, supports QPPV in management of the QPPV Office operations and contributes to and is responsible for realization of the QPPV Office strategic initiatives, improvements projects and innovation.
The PSMF and QPPV Office Manager collaborates and leads in providing guidance and oversight to ensure that functions contributing to the PSMF are compliant with the requirements of the relevant legislation.
Manages development and implementation of practical, risk-based solutions / processes that complement functional group practices.
Key Responsibilities
- Oversight, coordination, preparation, and review of the EEA and UK PSMF(s) and PSMF Summary in accordance with the assigned schedule and current legislation
- Provide PSMF related subject matter expertise
- Lead the improvements of QPPV and PSMF-related processes through strategic projects including automation
- Develop PSMF updates strategy and its execution in relation to evolving Company PV system
- Collaborate, and provide expertise to local PSMFs development / maintenance
- Manage the QPPV and PSMF mailboxes
- Manage QPPV and PSMF-related processes and procedural documents
- Chair periodic and ad-hoc meetings and perform document management activities
- Lead and deliver cross-functional improvement projects sponsored by the QPPV / QPPV Office
- Act as the trusted deputy for Eudravigilance and performs related operations.
Qualifications
What we are looking for
Required Qualifications
- Bio Science Degree, pharmacy or nursing degree.
- At least 6 years drug safety or clinical safety experience required
- Languages : English - C1 level minimum
- Solid / intermediate understanding and practical experience with MS Office (including MS Excel conditional formatting, editing;
experience with macros)
Desired Qualifications
- Experience with managing the EEA and / or UK PSMF.
- Strong tracking, coordination and project planning skills.
- Excellent customer service, interpersonal, communication and team collaboration skills.
- Strong influencing skills. Good communication skills, both written and verbal.
- Ability to identify and implement process and / or application improvements.
- Handling high volume of data and files simultaneously
- Technical skills : Adobe Acrobat Pro basics; SharePoints management, Visio, PowerApps and PowerAutomate
- Ability to work on multiple simultaneous tasks with limited supervision.
What’s in it for you
- Competitive Total Rewards Package*
- Paid Company Holidays, Paid Vacation, Volunteer Time & More!
- Learning & Development Opportunities
- Employee Resource Groups
- This list could vary based on location / region
- Note : Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.
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