Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically defined and medically prove... Visa mer
Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically defined and medically proven innovative solutions for the skin. For more information, please visit www.galderma.com.
Galderma, världens största oberoende globala dermatologiska företag, grundades 1981 och finns i 100 länder med en omfattande produktportfölj för behandling av olika hudåkommor. Företaget samarbetar med vårdpersonal världen över för att tillgodose människors dermatologiska behov under livets olika faser. Galderma är ledande inom forskning och utveckling av vetenskapligt definierade och medicinskt dokumenterade lösningar för huden och dess åkommor. Mer information finns på www.galderma.com/se
Do you want to join a leader in skin solutions and be part of an international company in a growth phase? Do you want to be at the heart of product safety and influence on a global level? Then this can be the role for you!
The Risk Minimization Physician role is part of the new global R&D organization dedicated to Pharmaceuticals and Aesthetics. The Pharmacovigilance department's mission is to protect customers and patients from safety issues as well as lead the scientific and operational activities relating to the detection, assessment, understanding and prevention of adverse effects. The Pharmacovigilance Risk Management team is truly global, with colleagues based in the USA, Sweden, France and Switzerland. The Risk Minimization Physician role is located in Uppsala, Sweden, to interact closely with colleagues from the center of excellence for Aesthetics. The position is directly reporting to the Head of Pharmacovigilance Risk Management. Few business travels are included in the role, mostly within Europe and to Switzerland.
As Global PV Risk Minimization Physician your mission will be to work with the benefit risk assessment for the Aesthetics product portfolio. Working with a cross-functional team, you will be accountable for the benefit-risk activities of Aesthetic products, including signal detection, risk management, risk mitigation plans, safety analyses in aggregate reports, medical review of ICSRs as needed etc.
You will lead the scientific review of safety-related information in CCDS, CSI, product labelling, investigator brochures, and DSUR/PSUR/PBRER, as well as respond to specific questions from Health Authorities.
As Risk Minimization Physician you will:
* Propose measures aiming at minimizing risks during clinical development;
* Organize and lead regular Product Safety Team meetings;
* Attend and present at Portfolio Safety Committee meetings as required;
* Review/provide input to Development Safety Update Reports (DSURs) and aggregate reports;
* Review/provide input to Risk Management Plans (RMP) and REMS;
* Review/provide input to Common Technical Document (CTD) or equivalent document for Dossier Registration and label;
* Contribute to Investigators/KOLs meetings for safety-related aspects/questions;
* Validate safety signals based on the review of single cases and aggregate data and escalate as appropriate;
* Ensure effective collaboration with stakeholders from the Clinical Development, Regulatory Affairs, Medical Affairs and Product Teams.
You have a Medical doctor degree, combined with additional qualifications in clinical pharmacology and/or pharmacovigilance and drug safety.
You have worked for at least 10 years in pharmaceutical/medical device companies at a global level. You bring significant experience and knowledge of International clinical development and post marketing regulations applicable to medical devices primarily but also to drugs.
You have a sound knowledge of the safety requirements for non-clinical and clinical development, registration process and post-marketing of medical devices. You can identify signals and propose appropriate risk mitigation/minimization actions in complex and critical situations. You are also used to interact with Health Authorities in the US, EU and other geographies to address medical safety and risk management questions.
You speak English fluently and are used to working with cross-functional teams. You know how to communicate and influence others to ensure compliance and deliver within agreed timelines. As a representative for Pharmacovigilance, you possess high ethical standards and use sound medical judgement in your decision making.
What we offer in return
As Galderma's Global Center of Excellence for Aesthetics, we have in Uppsala a unique edge as we have on our site the whole chain from product development to production. Here, our 450 employees work on our world leading brands such as Restylane®, Azzalure® and Sculptra®.
We are offering you the opportunity to work in an exciting, international environment where both professional and personal development is encouraged. We are based in modern offices and located just by the river (Fyrisån) in Uppsala, only a 10-minute bike ride from Uppsala central station.
We welcome your application (CV and letter) preferably via this career site or via our company website https://www.galderma.com/job-search. Apply as soon as possible though no later than January 30, 2021. The selection process is ongoing.
Should you have questions about this opportunity, you are welcome to contact Celine Bales, HR BP Visa mindre