Patient Safety Lead
Roche
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**
**You will be accountable for the implementation, maintenance and oversight of the local Pharmacovigilance (PV) System for Bosnia and Herzegovina and set the strategic direction for patient safety including risk management within the Affiliate, ensuring alignment with International Patient Safety priorities and local business needs.**
**Key Responsibilities**
General
+ Lead/facilitate Affiliate Patient Safety strategy and planning to enable effective prioritization for impact
+ Collaborate strategically with the global functions and affiliate leadership by leveraging country safety insights to determine priorities, shape organizational strategies, and influence regional and global decisions
Local PV System
+ Act as the local single point of contact for safety-related aspects, internally and externally, including the local regulatory authority
+ Local PV Officer/responsible person for pharmacovigilance as the named and qualified point of contact, holds responsibility for both establishing and maintaining the local PV system, and for guaranteeing adherence to local requirements mandated by the local Regulatory Authority
+ Lead the design, implementation, and maintenance of local PV processes and PV oversight
+ Enable operational excellence and maintain oversight of safety-related activities
+ Lead in shaping country PV regulation and the broader country pharmacovigilance ecosystem
+ Ensure business continuity and coordinate APS resources across the Affiliate
Local Safety Risk Management:
+ Lead safety solutions implementation and launch readiness activities
+ Identify, analyze and share safety insights by understanding disease areas (Roche portfolio, patient journey), engaging with key stakeholders, and ensuring timely, proactive integration into Affiliate and global strategies.
+ Lead safety risk management and external safety communications
+ Strengthen cross-functional and cross-country collaboration
**Who You Are**
+ Degree in Healthcare-related discipline (e.g., MD, PharmD, Dentistry), an MD/HCP qualification is a prerequisite
+ Residency in Bosnia and Herzegovina
+ Fluency in English, Bosnian, Serbian, and Croatian languages
+ Proven (3+ years) work experience in clinical research, development, or related field, including a minimum of 3 years in PV or Safety at the affiliate and/or regional level
+ Demonstrated experience of collaborating or leading in global and local matrix environments, including proven ability in stakeholder management and influencing
+ Expertise in decision-making in the local & global PV Ecosystem, including medical device regulation
+ Experience in interaction with Health Authorities
+ Advantage: Experience in other affiliate medical functions (e.g., Medical Affairs, Clinical Operations, Medical Information) or global functions such as Clinical Safety
+ Advantage: Matrix or “Visionary, Architect, Catalyst, Coach (VACC)” leadership skills with a proven track record
**_Please submit your CV in English._**
**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.**
Confirm your E-mail: Send Email
All Jobs from Roche