Benefit Risk Management (Specialist/Analyst)
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.
Position Title -Benefit Risk Management (Specialist/Analyst)
Location - Electronic City - Bangalore
Your Role:
- Provide guidance, oversight and lead execution of the processes related to Benefit-Risk Management and various PV activities including, but not limited to Periodic Safety Reports Management, Signal Detection, Risk Management Plan activities and other PV tasks.
- Lead end to end PV activities with regards to planning activities, developing schedules, and creating of charts and presentations.
- Plan, organize and conduct meetings related to key PV activities with internal and external stakeholders, including generation of well written and accurate meeting protocols.
- Retrieve data for various safety reports from internal and external stakeholders, and business partners, including monitoring the contributions delivery timelines.
- Ensure oversight and coordination for review of safety documents for data accuracy and consistency with the SOPs, Templates, and Guidelines.
- Ensure data consistency, accuracy, quality and timely entry within the IT Tools for the applicable tracking tasks.
- Prepare distribution of safety reports for the submission to the recipients as per processes, timelines, and regulatory requirements.
- Overseeing compliance, such as deviation and CAPA activities, preparation of metrics and analysis of KPIs.
- Act as an SME in audits and inspections for the products of responsibility, as required.
- Tracking of safety commitments and quality findings from health authority assessments reports, as well as commitments to Marketing Authorization, if applicable.
- Manage and lead continual improvement of related PV IT tools.
- Manage and lead continual improvement of the PV processes and tools and their documentation.
Who you are:
- Graduate degree or equivalent job experience with comprehensive pharmacovigilance knowledge of theories, principles and concepts, Masters/PhD or advanced science degree.
- Excellent level of written and spoken English.
- Minimum 2-5 years of professional experience in patient safety/PV.
- Experience in safety project management in international settings.
- Demonstrated experience in Periodic Safety Reports / Aggregate Safety Data coordination activities, Signal Management and B/R Assessment.
- Excellent organizational skills, combined with an ability to follow projects to completion, and adapt rapidly to changing priorities.
- Self-motivated, confident, strong team player and excellent networking skills.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it 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 our diverse team!
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