Patient Safety Intern

Job description

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**



**The Opportunity**



The Patient Safety Intern will support the pharmacovigilance team in ensuring patient safety by assisting with the collection, documentation, and reporting of adverse events (AEs), as well as contributing to safety data analysis and compliance with regulatory guidelines.

This internship offers a unique opportunity to gain hands-on experience in pharmacovigilance processes and make a meaningful contribution to improving healthcare outcomes.



**Main Responsibilities**



Pharmacovigilance Support

- Assist in the intake, documentation, and follow-up of adverse event reports from various sources, ensuring compliance with regulatory timelines.

- Active contribution, under Patient Safety Lead supervision, via delegated tasks to the efficiency of Safety-related activities relevant to the PV system in partnership with the Pharmacovigilance Hub(s) to ensure monitoring of the safety profile of Roche products and their safety risk management, meet regulatory requirements, and ensure license to operate

- Support with all Pharmacovigilance tasks delegated by the patient safety leads



Regulatory Compliance

- Help ensure compliance with Good Pharmacovigilance Practices (GVP) and other local and global regulatory requirements.

- Assist in the submission of periodic safety reports and compliance documentation as per the local and global regulatory requirement.

- Contribute to the safety risk management of the registered products and implementation of Risk minimization tools in compliance with global and local regulatory requirements.



Data Analysis and Reporting

- Contribute to the collection and organization of safety data for analysis and reporting.

- Assist in identifying trends or potential safety signals under guidance.



Collaboration and Partnership

- Collaborate with internal teams, (e.g. Medical, Access, PJP/HSP, regulatory affairs, etc), to support pharmacovigilance activities.

- Liaise with external stakeholders (Service provider and Business partner) to insure a full compliance to the Pharmacovigilance Agreements.



Administrative Support

- Help maintain pharmacovigilance records and documentation in an organized manner.

- Assist in audits, inspections, and quality assurance processes as required.



**Who you are**



**Required Experience and Qualifications:**



- Currently enrolled in or recently graduated in Pharmacy, Medicine, Biomedical Science, Life Sciences, or a related field.

- Fluency French, Professional proficiency in English is highly preferred



- Experience: Previous academic exposure or internship experience in Pharmacovigilance (PV), Regulatory Affairs, Clinical Trials, or Quality Assurance is highly advantageous.

- Foundational understanding of the principles of Good Pharmacovigilance Practices and the drug development lifecycle.

- Regulatory Compliance: Basic knowledge of local (African regulatory bodies) and international (global) regulatory requirements for Adverse Event (AE) reporting and periodic safety reporting.

- Proven ability to handle, organize, and maintain detailed, sensitive records.

Strong competence in accurate data entry and adherence to strict compliance timelines.

- Basic analytical skills to contribute to the organization of safety data and assist in the preliminary identification of potential safety trends or signals.



**Skills and Competencies**

- Attention to Detail

- Initiative and Independence

- Collaboration and Communication

- Problem-Solving



**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.**

Required Skill Profession

Other General