About the role
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position
Key Responsibilities:
- Act as Deputy Qualified Person for Pharmacovigilance (Deputy QPPV) for Ukraine and Moldova, with involvement in and understanding of all local PV activities and processes
- Maintain the local PV system in compliance with local legislation and global company standards
- Manage and oversee ICSRs, including cases related to clinical trials and medical devices
- Manage safety aggregate reports, including PBRERs, DSURs, A13 submissions, and other regulatory safety documentation
- Coordinate DHPCs and other safety communications
- Monitor safety information sources (medical literature, local regulatory authorities) and support local signal management activities
- Participate in internal audits and regulatory inspections
- Manage and oversee internal and external partners, including safety agreements and reconciliation activities
- Monitor changes in local PV and regulatory legislation
- Collaborate with regulatory authorities, direct market service providers, global teams, and external partners
- Support cross-functional internal projects and initiatives
- Conduct initial and refresher PV training sessions for internal and external stakeholders
Requirements:
- English level: Intermediate+ / Upper-Intermediate (confident understanding of written and spoken communication, participation in business discussions, and communication with international teams)
- 2+ years of experience in PV within a pharmaceutical company
- Strong knowledge of Ukrainian PV and regulatory requirements
- Experience interacting with regulatory authorities
- Strong sense of responsibility and self-organization
- Ability to work effectively in a dynamic environment and adapt quickly to change
- Fast learner with the ability to quickly absorb new information
- Strong attention to detail, deadline and accuracy
- Well-developed communication and cross-functional collaboration skills
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
Aplyr's read
Roche is a leader in pharmaceuticals and diagnostics, known for its innovative approach to improving healthcare. It attracts professionals passionate about scientific advancement.
What's promising
- •Roche invests heavily in R&D, driving innovation in pharmaceuticals and diagnostics.
- •The company offers diverse career opportunities across various scientific and business disciplines.
- •Roche's global presence provides employees with international career growth and collaboration opportunities.
What to watch
- •The highly regulated industry may lead to slower decision-making processes.
- •Roche faces intense competition from other pharmaceutical and diagnostics companies.
- •Job roles may require specialized expertise, limiting broader career entry points.
Why Roche
- •Roche integrates pharmaceuticals and diagnostics, offering a comprehensive healthcare approach.
- •The company has a strong focus on personalized medicine and targeted therapies.
- •Roche's commitment to sustainability and innovation sets it apart in the healthcare industry.
Aplyr’s read is generated by AI from public sources. Was it useful?
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The company is known for its innovative medicines and diagnostic tools.
