Senior Expert
2 weeks ago
Work Your Magic with us
Ready to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Your Role
As Senior Expert Regional Pharmacovigilance in the Process Management and Process Excellence Team in RQS Operations (Regulatory, Quality and Safety) you will focus on simplifying the RQS process landscape. You will implement a risk-balanced approach to process management and, as an essential partner to RQS functions (and beyond) you will drive an agenda of continuous improvement by driving the following key activities:
- Supporting PV activities for different countries in close collaboration with Global Patient Safety (GPS) Team and other stakeholders within RQS Operations.
- Maintaining the local PV system and its documentation in local PV System Master Files in accordance with global / local legislation and company standards.
- Authoring and/or co-ordinating and reviewing local Risk Management Plans.
- Driving improvement and automation initiatives, including selecting and implementing suitable AI-based tools for simplification of the processes in scope.
- Maintaining audit- and inspection-readiness at all times of the processes and documentation in scope of the role.
- Applying a risk-based approach to prioritization of tasks and projects.
Who You Are
Minimum Requirements:
- Master's degree or equivalent in pharmacy or life-sciences
- Minimum of 8 years' experience in the pharmaceutical or CRO industry, covering at least three of the following areas within post-marketing pharmacovigilance:
- Set-up and maintenance of a PV system (global / local / regional), authoring / review of local PV System Master files.
- Track record of acting as Business Process Owner for a PV-relevant process.
- Proven successful interaction between local and global PV functions.
- Thorough understanding of Safety risk management and implementation of additional Risk Minimization Measures
- Proven successful involvement in audits and health authority inspections.
Preferred Requirements
- Licensed pharmacist or Ph.D. in life sciences.
- Proven track-record of working in a global industry environment.
- Ability to handle urgent priorities across different, requirements and time-zones.
- Pro-active, solution-and customer- oriented mindset.
- Excellent communication skills in English, written and spoken, other languages are an asset.
- Ability to successfully work in a multicultural environment and to foster an atmosphere of mutual understanding.
- Experience with AI Tools and project management are additional assets.
What we offer:
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity
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