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The Position

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

Who we are

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.