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Vaga de parceiro
Drug Safety & Customer Service Manager - São Paulo / SP
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O que você irá fazer
In Research & Development , were continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve.
Youll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the life of patients for the better and help us make progress towards our vision of a world free of pain.
Join us today, and discover the difference you can make.
Responsible and accountable for the local Grünenthal (GRT) pharmacovigilance (PV) system in the territory supporting the business in compliance with global standards as set by the Head of Global Drug Safety/European and United Kingdom Qualified Person for Pharmacovigilance and the local legal requirements to ensure patient safety for products where GRT is responsible.
What the job looks like: Each day you'll enjoy a variety of challenges, such as: Act as the internal Local Responsible Person for Pharmacovigilance (LRP-PV) for the territory and external national PV responsible person as required by the Competent Authority (including nomination to the authority, as required); thereby acting as the primary local point of contact for the local PV system and PV inspection/audit activities.
As required by local legislation or in cases of local products, to be available on a 24 hours a day, 7 days a week basis or establish a back-up procedure including business continuity.
Therefore to appoint an appropriately qualified person as LRP-PV Deputy with the necessary means to fulfil the required tasks.
Responsible and accountable for the local PV system, facilities, resources, budget and empowered to make necessary decisions within the global GRT PV system.
It is important to maintain current knowledge of the local PV legislation to ensure local PV compliance and integration in the global PV system.
Therefore to maintain, develop and oversee the local pharmacovigilance (PV) system (i.
e.
local PV quality management system including any local standard procedural documents), within a global PV system, ensuring patient safety for products where GRT is Marketing Authorization Holder or has contractual obligations.
Ensure appropriate secure filing and archiving of the local PV-related documentation/data.
Ensure relevant PV training to all local employees, according to job requirements and to ensure reporting of safety information to Drug Safety.
This information includes collection of all available safety information, incomplete cases, cases from spontaneous sources or organized data collection programs or literature.
Drug Safety will perform follow-up activities as required and support the submission of safety information as single cases or aggregate reports to the Competent Authorities or business partners, according to PV regulations, GRT processes and contractual requirements.
Ensure prompt escalation of safety issues within Global Drug Safety so the information can be assessed and PV measures implemented to maintain the benefit safety profile for any product.
For any defined local products it is important to ensure PV tasks are completed to maintain the benefit safety profile.
Therefore as required or according to the Risk Management Plan, local implementation management of risk minimization measures may be required according to those measures defined for the product.
What you'll bring to the table: Scientific degree (e.
g.
pharmacist, biological sciences) Local language, Business English language, Microsoft based and general IT competence Flexible and solution orientated mindset for representing Drug Safety within commercial affiliate while working within a Global Drug Safety department.
Relevant experience in the pharmaceutical industry; pharmacovigilance capabilities highly desirable.
Grünenthal is a global leader in pain management and related diseases.
As a science-based, fully-integrated pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide.
Our purpose is to change lives for the better and innovation is our passion.
We are focusing all of our activities and efforts on working towards our vision of a world free of pain.
Grünenthal is headquartered in Aachen, Germany, and has affiliates in 27 countries across Europe, Latin America and the US.
Our products are available in approx.
100 countries.
In 2023, Grünenthal employed around 4,400 people and achieved revenues of 1.
8bn.
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