Do you bring experience working in Drug Safety? Do you bring know-how in the area of Regulatory Affairs? Are you committed to learning and developing your skills, further? Our team in Buenos Aires is growing and in this newly created position, we are seeking a Regional Drug Safety and Regulatory Affairs Coordinator. You will be responsible to oversee and manage daily regional pharmacovigilance activities in addition to acting as the responsible point of contact for LATAM partners regarding label implementation. You will report directly to the LATAM Medical Affairs Director with a dotted line to the LATAM Regulatory Affairs Director. Tasks and responsibilities will include:
Individual Case Safety Report management supporting Peru LDSR
PV related quality management system responsible for LATAM Office and supportive to Peru
The ideal candidate will bring a degree in a Life Sciences field, in addition to the following experience (not exclusive):
You are an effective independent worker and are able to convince others of the importance of being PV compliant. You are able to read situations, are a focused listener and can negotiate tough agreements and settle disputes equitably, by finding common ground and getting cooperation with minimum noise. You have high attention to detail and work with a high level of accuracy, enabling you to effectively write SOPs. You are able to manage multiple projects in parallel and prioritise tasks, accordingly. You work constructively and well with others and you are motivated by working as part of a team. You communicate in a proactive, honest and clear way and are able to communicate difficult news clearly in a timely manner. You are results-oriented, you get things done and keep focused on tasks. You work in line with the Vifor Pharma values.
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives. Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world. The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.
Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are.