Are you passionate about ensuring the safety of medicines and protecting patient health?
Do you have experience in clinical trials?
We are looking for a Pharmacovigilance Specialist to join our team in South Africa.
If you are detail-oriented, have strong communication skills, and are dedicated to ensuring the safety of pharmaceutical products, then read on and apply today for a life-changing career.
This position will be based in Johannesburg, South Africa under the Clinical trials department.
You will directly report to the CDC South Africa Director.
The Position As a Pharmacovigilance Specialist at Novo Nordisk, you will be reporting Serious Adverse Events (SAE) to Global Safety (GS) and Independent Ethics Committees within specified timelines.
In addition, you will report Serious Adverse Drug Reactions (SADRs) to the South African Health Products Regulatory Authority (SAHPRA) as per the SAHPRA guidelines and trial-specific approval letters.
Your main accountabilities will be: Handling of Developmental Safety Update Reports (DSUR) Handling of Data Monitoring Committee (DMC) Recommendations Compilation of trial-specific safety progress reports to SAHPRA Capturing of CIOMs and SUSAR (Daily Listings) into the trial-specific workbook and preparation of Line Listings for 6-monthly Progress Reports/Annual Reapproval for reporting to the Regulatory Authority and Ethics Committees as per requirements This position allows a hybrid model to work from home and from the office a few days per week, is a long term position however is part time 80 hours per month.
Qualifications As a Pharmacovigilance Specialist you will need to have 2-4 years of experience in clinical trials, preferably in the pharmaceutical/clinical research industry.
To be successful in this role, you should have: Experience in clinical trials with a broad understanding of pharmacovigilance processes Great attention to details Good communication and negotiation skills Excellent time management and organizational skills Experience in working with IT systems (such as Cosmos, EDC) Fluency in English About the Department The Pharmacovigilance Specialist position is based in South Africa.
Our department is responsible for ensuring the safety of medicines and protecting patient health.
We work closely with Global Safety, the South African Health Products Regulatory Authority and Independent Ethics Committees to report adverse events and reactions promptly.
Our team is dedicated to compliance with regulatory authorities and ensuring the safety of pharmaceutical products throughout their life cycle.
Working at Novo Nordisk At Novo Nordisk, we don't wait for change.
We drive it.
We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future.
We embrace the spirit of experimentation, striving for excellence without fixating on perfection.
We never shy away from opportunities to develop, we seize them.
From research and development to manufacturing, marketing, and sales – we're all working to move the needle on patient care.
Contact Please click on "apply now" to submit your resume in English.
Deadline Apply before 26th August 2024 We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world.
We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures.
We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in.
Together, we're life changing.
