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
Job description / Arbetsbeskrivning
As the Senior PV Associate 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 part of cross-functional teams within the company to provide PV support as assigned.
Job responsibilities / Ditt uppdrag
Your main tasks:
* Ensures regular and ad hoc safety data trending, signal detection and validation activities
* Contributes to the regular post-market surveillance review meetings. Coordinates and compiles the post-market surveillance plans and periodic safety update reports (PSURs) and other aggregate safety reports
* Contributes to relevant documentation for regulatory submissions for product registration, design changes and renewals, etc.
* Maintains and coordinates compilation of product Risk Management documentation
* Contributes to safety sections in the product Clinical Evaluation reports and Post-Market Clinical Follow-up reports
* Prepares responses to Competent Authorities or Notified Body for questions related to product safety
* Updates safety sections of product labelling, including the Instructions for Use or other reference safety information and patient brochures
* Supports 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
* Participates in the writing/review of the department quality documents and the training of internal and external functions
Minimum requirements/ Är du den vi söker?
* University Degree in Pharmacy or Life Sciences, ideally PhD
* Fluency in English, Swedish preferable
* Minimum 5 years of experience within pharmacovigilance/medical devices vigilance in the pharmaceutical/medical devices industry
* Solid knowledge of risk management and signal detection standards and methodology
* Expertise in the medical device/pharmaceutical regulations in Europe and US
* Analytical skills with a capacity to interpret and compile large amounts of data and to read and understand regulations
* Excellent organization skills and the ability to plan work so that it is efficient and effective
* Independency and ability to take decisions to deliver results
* Experience in collaborating with cross-functional teams in an international setting
* Flexibility and ability to adapt in a fast-changing business environment
* Positive and open-minded attitude
Other important information/ Frågor och ansökan
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 550 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) via this career site or alternatively, via the link "Ansök / Apply Now". Apply as soon as possible though no later than August 16. The selection process is ongoing. Visa mindre