Pharmacovigilance Associate Analytics and Reporting
Q-Med AB / Maskiningenjörsjobb / Uppsala
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hela Sverige About Galderma
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. Do you want to join a business that contributes to human skin health solutions and well-being? Do you want to be at the heart of product safety on a global level? Would you like the possibility to contribute in different life-cycle stages, from early product development to post-marketing? Then this can be the role for you!
The Pharmacovigilance Associate Analytics and Reporting 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 following the use of our products.
The Corporate Pharmacovigilance department is truly global, with colleagues based in the US, Sweden, France and Switzerland. The team has a global responsibility for ensuring compliance with vigilance and risk management obligations for all Galderma Medicinal products, Medical Device and Cosmetic products. The Pharmacovigilance Associate Analytics and Reporting is a full-time position, office based in Uppsala, and reporting to the Global Head of PV Data Surveillance, Analytics and Reporting. The team in Uppsala consists of 5 PV associates working with safety risk management activities for Galderma's medical device products, but also an increasing scope of work for medicinal products.
Job responsibilities
As PVA Analytics & Reporting within the Corporate PV department you will manage regular safety monitoring activities and compilation of periodic aggregate safety reports as part of our post market surveillance activities. You will also be responsible for maintaining product Risk Management documentation and preparing different safety-related reports for regulatory submissions. You will be a part of cross-functional teams within the company to provide PV support to product development projects and clinical development programs. The position is primarily focused on our medical device products but could also include similar tasks for medicinal products within our portfolio.
As PVA Analytics & Reporting you will:
* Ensure regular and ad hoc safety data trending, signal detection and validation activities.
* Contribute to the regular post-market surveillance review meetings. Coordinate and compile the post-market surveillance plans and periodic safety update reports (PSURs) and other aggregate safety reports.
* Contribute to relevant documentation for regulatory submissions for product registration, design changes and renewals, etc.
* Maintain and coordinate compilation of product Risk Management documentation.
* Contribute to safety sections in the product Clinical Evaluation reports and Post Market Clinical Follow-up reports.
* Prepare responses to Competent Authorities or Notified Body for questions related to product safety.
* Update safety sections of product labeling, including the Instructions for Use or other reference safety information and patient brochures.
* Support study design discussions and compilation of safety sections of protocols, study reports, Investigator brochures, development safety update reports (DSURs) and other applicable documentation for studies.
* Participate in the writing/review of the department quality documents and the training of internal and external functions.
Minimum requrements
You have a Pharmacist or Life Science degree, MSc/PhD, and several years of experience within pharmacovigilance/medical device vigilance in the pharmaceutical/medical device industry, and with a good knowledge of risk management standards and methodology. Knowledge of the new medical device regulations in Europe is a merit.
You need to be analytical with a capacity to interpret and compile large amounts of data. You should be fluent in English and Swedish and have excellent writing skills in English. As a person you need to be highly motivated, organized and structured, with a great ability to prioritize and make things happen. It is important to be able to work independently and take decisions to deliver results and to be able to cooperate and work in cross-functional teams in an international environment. We expect you to be flexible, be able to adapt in a fast-changing business environment and have a positive open-mind attitude.
Other important infromation
We welcome your application (CV and letter in English) via this career site or alternatively, via our company website
https://www.galderma.com/job-search. Apply as soon as possible though no later than January 31, 2021. The selection process is ongoing.
Should you have questions about this opportunity you are welcome to contact the recruiting manager Christer Atuma, Global Head of PV Data Surveillance, Analytics and Reporting, at 018-474 90 00.
We do not wish to be contacted by recruitment agencies for this recruitment at this stage.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2021-01-20ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2021-01-30
Klicka på denna länk för att göra din ansökanFöretagQ-Med AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "109400046".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Q-Med AB (org.nr 556258-6882)
Arbetsplats Galderma
Jobbnummer 5531773
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