Pharmacovigilance Specialist Deputy QPPV
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Job Summary
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.
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
A healthier future drives us to innovate. Together more than 100000 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.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
IC
About Company
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.
