Pharmacovigilance & Safety

hace 3 semanas

Barcelona, España LEO Pharma A tiempo completo

**Field of work**:Clinical Development**Posting Date**:09-Mar-2023**Application deadline**:
**Location**: Barcelona 08003,, Spain
**Contract type**: Permanent
**Job ID**: 563**Senior Pharmacovigilance Specialist**
- LEO Pharma has embarked on an ambitious journey to become the preferred dermatology care partner improving people’s lives around the world - and that is why we need you.
- You can play a significant role in making this vision come true as you will be a key player in driving the pharmacovigilance agenda in Spain together with the Global LEO Pharma PV community.
- In Global Safety Regions you will get the opportunity to shape the future and help people with skin diseases live more fulfilling lives by advancing the standard of care.
Role Description

**Your role - Senior Pharmacovigilance Specialist**
- As senior pharmacovigilance specialist your overall responsibility is to keep patients at the heart of what we do by ensuring the continuity of all PV activities in Spain. To become a success in this role it is crucial you are great to collaborate and that you follow the strategic direction for Global Safety Regions including the establishment and maintenance of globally and when needed locally standardized practices to ensure compliance with international and national regulations.
You will be supporting the corporate business strategy into tactical short
- and long-term strategies acknowledging local obligations and strategies.**Reponsibilities**
- Provide performance and compliance oversight for own area, and specify new processes and standards to secure license to operate
- Manage knowledge and best practices within the PV organization
- Ensuring timely management of PV deviations and risk mitigation by defining appropriate CAPAs
- Responsible for bridging local to global and global to local by communicating transformations and changes related to the local organization
- Support update of the Global PSMF
- National contact person to competent authorities
- Responsible for PV training of LEO Pharma employees
- Process safety information from spontaneous or solicited cases
- Prepare and validate local PV contracts
- Responsible for local PV deliverables
- Responsible for monitoring of LEO Pharma social media
- Ensure regulatory reporting of cases from interventional clinical trials including DSUR
- Ensure regulatory surveillance of PV
- Manage PV for Patient Support Program (PSP), Monitoring Registry (MR) and keep informed about Investigator-initiated studies (IIS)
- Support audits & lead local PV Inspections

**Your qualifications**
- You have a strong and proven track record with Pharmacovigilance and it’s deliverables. Your strong systematic mindset allows you to solve problems. Importantly, you are self-driven and ambitious, and it is crucial that you are great to collaborate.
To succeed in this role, we imagine that you have the following qualifications:
- Batchelor or Academic degree in life science, with a minimum of 4 to 5 years' experience in pharmacovigilance (post-marketing and clinical trials)
- Solid knowledge of local and EU PV regulations
- Have strong command of English, written and spoken
- This is a hybrid position with the opportunity of working from home 2 days per week.**Your new team**
- As senior pharmacovigilance specialist you will join a department of 25 dedicated and highly talented and ambitious pharmacovigilance specialists located all over the world.
This is an interesting job with great opportunities for both personal and professional development.
We believe that the best results are made in an atmosphere of trust and respect for the individual and we simply care about each other.- You will be located in LEO Pharma Spain, and report into the Head of Global Safety Regions located in Denmark.- You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest.**Let's pioneer together**
- At LEO Pharma, we help people with skin diseases live fulfilling lives by advancing dermatology beyond the skin. We drive dermatology with our knowledge, collaboration, and curiosity, and we are at the forefront of science in developing new medicines. For us, pioneering together is about constantly improving and extending what’s possible for each other, our company, and our patients.
For certain positions, LEO Pharma might complete a background check conducted by a third party.

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