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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 knowledge of medical terminology
Knowledge of global Pharmacovigilance regulatory requirements
Ability to evaluate, analyze and interpret data and draw conclusions independently
Strong organization skills, detail oriented, ability to adapt to change
Effective team player, demonstrating initiative and accountability
Good interpersonal skills, builds strong sustainable and collaborative relationships with internal and external stakeholders, as well as effective collaboration with functional groups and management
Good communication skills, both written and verbal
Identify improvement areas and provide creative problem solving in a complex process-focused environment
Ability to work under pressure and convey a sense of urgency
Ability to work across cultures, including in a virtual environment
Proven ability to demonstrate Roche Values
Computer literate
Highly Weighted Competencies:
Technical and Business Expertise, Communication, Teamwork and Collaboration, Achieving Results
Other: Fluent in English - verbal and written
Travel Requirements: None
Why This Role?
You'll have the unique opportunity to play a crucial role in safeguarding public health and ensuring patient safety. This role offers a chance to work within a collaborative and innovative environment, where your expertise will directly impact the quality of pharmaceutical care. Based in Midrand, you'll be part of a global network dedicated to excellence in pharmacovigilance, with access to growth opportunities, professional development, and meaningful contributions to life-saving medicines. If you're passionate about making a difference and value a career with purpose, this role is perfect for you.
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.