Læge - Quality Manager
3 job matcher din søgning
LEO Pharma, Ballerup
We are looking for an experienced Pharmacovigilance Advisor in the PV Science department which is part of the Global Pharmacovigilance headquarters in Ballerup.
As a Principal PV Advisor you are globally responsible for effective safety risk management processes for both drug candidates under clinical development and marketed products.
Some of the main tasks included in this responsibility are:
- on-going signal detection and management
- chairmanship of cross-organisational groups (Safety Management Teams) looking at safety risk management from all aspects
- participation in cross-organisational clinical development teams providing safety input to clinical development discussions
Ferring Pharmaceuticals A/S, Copenhagen
The Project Director is the owner and point of reference for the project plan. He/she is the link between functional teams to move approved projects forward. The Project Director is responsible for delivering the agreed project plan to the agreed timelines, the agreed costs and the required quality standards. He/she facilitates the process for defining and updating the TTP/MAP (Target Product Profile – Minimum Acceptable Profile), and the expert input.
Accountabilities for this position:
- Establish and steer a cross functional team to ensure an integrated development of a project
- Define and plan the development plan including senior management go/no go decision points to be applied at milestones and gates
- Considers and proposes alternative development scenarios highlighting opportunities, risk, budget and timelines
LEO Pharma, Ballerup
We are looking for an experienced PV Physician/Advisor for the PV Science department in Global Pharmacovigilance to become part of a growing team working with systemic treatments for atopic dermatitis and psoriasis. You will primarily be working with the human monoclonal antibody tralokinumab which is currently in development for treatment of atopic dermatitis.
As a Senior PV Physician/PV Advisor you are globally responsible for effective safety risk management processes for your assigned product(s) with main tasks being:
- Signal detection and management
- Participation in clinical trial teams providing safety input to clinical development discussions and documents, e.g. trial protocols and Investigator’s Brochure
- Preparation of PV input to various regulatory documents