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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.

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.