Pharmacovigilance Associate Data Surveillance to Galderma

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. 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

Job description
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 clinical development to post-marketing? Then this can be the role for you!

The Pharmacovigilance Associate Data Surveillance 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 Data Surveillance 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 conducting safety risk management activities for Galderma's Medical Device products primarily, but also having an increasing scope of work for Medicinal products.

Job responsibilities
As PVA Data Surveillance within the Corporate PV department, you will manage regular case processing activities, including post marketing case reports and safety case reports from clinical studies, and oversee external PV service providers. You will also be responsible for safety data extractions and supporting the preparation of various safety-related reports for regulatory submissions. You will be a part of cross-functional teams within the company to provide PV support to clinical studies. The position is primarily focused on our Medical Device products but will also include similar tasks for Medicinal products within our portfolio.

As PVA Data Surveillance, you will:

* Process safety cases in the global PV database, including medical coding using current dictionaries (MedDRA, WHO drug) and writing of PV Company comment, be involved in CAPA assessment and narratives, and submit reportable cases to Competent Authorities globally in compliance with applicable regulatory requirements.
* Contribute to safety data exchange and data reconciliation activities with contractual Partners, affiliates and distributors.
* Ensure training and oversight of external service providers for case processing activities and perform quality control of safety cases to ensure data consistency.
* Contribute to the safety management plans, study protocol and case report forms for clinical trials in collaboration with the clinical study team, be responsible for handling and reporting serious adverse events to Competent Authorities and for database reconciliation activities.
* Ensure regular and ad-hoc safety data extractions for clinical study and post marketing safety data reviews, provide input into responses to regulatory authority queries, KPI and compliance monitoring and compilation of various aggregate safety reports.
* Contribute to the maintenance of the global safety database, and case data entry and coding conventions.
* Participate in the writing and review of the Quality/PV department's quality documents and the training of internal and external functions.

Minimum requirements
You have a Pharmacist or Life Science degree (MSc), and at least two years of relevant experience within pharmacovigilance/medical device vigilance in the pharmaceutical/medical device industry. You have substantial computer proficiency with standard software programs and good general computer literacy. Previous experience from a drug or device safety system environment and MedDRA coding is desired. Experience from working on database validation activities, and with data extraction or data mining tools, including advanced Excel skills, is a merit.

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 an international environment. We expect you to be flexible, able to adapt in a fast-changing business environment and have a positive open-minded attitude. You possess good communication skills in English and Swedish, both verbal and written.

Your application
We welcome your application (CV and letter in English) via this career site. Apply as soon as possible though no later than March 21, 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.