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The Opportunity
As the Patient Safety Lead you will be accountable for the implementation, maintenance and oversight of the local PV system for Saudi Arabia and sets the strategic direction for patient safety including safety risk management within the Affiliate, ensuring alignment with global priorities and local business needs.
Your Responsibilities
PV System:
Act as Local Qualified Person for Pharacovigilance (QPPV), holding responsibility for both establishing and maintaining the local PV system, and for guaranteeing adherence to Roche global and local requirements.
Lead the design, implementation, and maintenance of local PV processes and PV oversight, ensuring they are effective and efficient.
Enable operational excellence and maintain oversight of safety-related activities relevant to the PV system through collaboration with key stakeholders to ensure license to operate.
Key areas of oversight/activities include the following in line with Roche standard operating procedures (where applicable):
Individual Case Safety Reports (e.g. data collection and submissions to HA), Signal Detection & Management, Aggregate safety reports, Pharmacovigilance Agreements, Risk Management and Safety Communication (e.g., Direct Healthcare Professional Communication, Risk Minimization Measures, emerging safety issues), Studies, Programs and other projects with PV implications (e.g., ICT, NIS, PASS, PAES, MAP, PAA, CUP, PTAP, Dicela), Safety Labeling and PV Commitments and (Local) Pharmacovigilance System Master File.
Lead in shaping country PV regulation and the broader country pharmacovigilance ecosystem as required
Local Safety Risk Management:
Lead safety risk management and external safety communications: Implement risk minimization strategies and ensure transparent, timely safety communication to healthcare professionals, patients, and external stakeholders, in partnership with relevant cross-functional teams.
Lead safety solutions implementation and launch readiness activities and ensure that patient safety risk management needs are addressed for Roche portfolio in the country.
Identify, analyze and share safety insights by understanding disease areas, engaging with key stakeholders, and ensuring timely, proactive integration into Affiliate and global strategies.
Who You Are
Degree in healthcare-related discipline (e.g., PharmD, Pharmacy)
Licensed pharmacist by the Saudi Commission for Health Specialities
At least 3-5 years 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.
3+ years experience collaborating or leading in global and local matrix environments, including proven ability in stakeholder management and influencing
Experience and expertise in decision-making in the local & global PV Ecosystem
Experience and expertise of relevant PV and 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 VACC leadership with proven track record
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.