Pharmacovigilance Hub Partner

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The Position

Join us in Roche Pharma based in Midrand as a Pharmacovigilance (PV) Hub Partner.

This position is responsible for supporting PV activities within the PV hub coverage areas to ensure PV activities are completed consistently in a timely manner in accordance with internal processes and local and international regulatory requirements. 

In this pivotal role, you will be at the heart of pharmacovigilance, collaborating with cross-functional teams to uphold the highest standards in drug safety and regulatory requirements.

Key Challenges
Your Primary Responsibilities and Accountabilities:


* Ensures collection, reporting and handling of safety information associated with Roche products is performed according to global Roche and local regulatory requirements within the assigned PV hub coverage areas.


* Proactively manages workload to ensure regulatory timelines are met.


* Records management coordinator for the PV unit.

Key Activities


* Performs accurate data capture of adverse event reports, for Roche products from Clinical trials, Post-Marketing Studies (PMS), Spontaneous Reports, Market Research and Patient Support Programs (MAPs), etc.

associated with Company products onto the safety database in accordance with internal processes and local and international regulatory requirements.


* Performs post surveillance activities such as literature review and media monitoring.


* Performs reconciliation activities associated with Pharmacovigilance Agreements and various other sources such as product complaints, medical information inquiries and MAPs.


* Assists and supports department with documentation management.


* Performs and documents contact tests for drug safety to test the mechanisms of reporting to Local Safety Unit.


* Responsible for keeping relevant databases up to date.


* Supports the PV-hub team in ensuring high standards are maintained and opportunities for departmental improvements are identified and implemented.


* Participates in PV project work when necessary and when deemed appropriate by the PV Hub manager.

Who You Are as an Ideal Candidate:
Education/Qualifications

Minimum: Health Care Professional Degree (e.g.

Pharmacist, Registered Nurse, Bachelor of Science in Nursing, Physician assistant, Nurse Practitioner) or Life Science Degree (e.g.

BSc Biology, BSc Neuroscience, etc.)

Experience, Skills, Knowledge:


* Previous operational experience in Drug Safety/Pharmacovigilance (preferred)


* Strong knowl...