Pharmacovigilance Specialist - Frankfurt am Main, Deutschland - Syneos Health Clinical
Beschreibung
Overview
Base location:
Neu-Isenburg
Regions covered:
Germany
The Global Safety Regions Specialist (GSRS) will follow the strategic direction for Global Safety Regions while establishing and maintaining it globally.
The GSRS will provide performance and compliance oversight for the specific region and specify new processes and standards to secure licenses to operate.
Responsibilities
- Fulfill the role and responsibilities of the Deputy Safety Contact Person
- Prepare and conduct Pharmacovigilance (PV) training for our customer's local employees and nonPV staff including external service providers
- Support bridging the localtoglobal and globaltolocal by communicating transformations and changes related to the local organisation
- Ensure reporting of SUSARs (Suspected Unexpected Serious Adverse Reaction) from interventional clinical trials including DSUR (Development Safety Update Report) to authorities and ethic committees
- Actively participate in departmental and various crossfunctional project teams that may include Regulatory and Medical Affairs
- Understand current brand strategic plans and objectives and provide appropriate input into the development and evolution of these plans and their related tactics
- Participate in and lead Global Safety projects
Job Requirements
- Bachelor or Academic degree in life science.
- Experience in pharmacovigilance (postmarketing and clinical trials)
- Good knowledge of local and European PV regulations
- Fluent in spoken and written German and English
- Good understanding of data
At Syneos Health, we believe in providing an environment and culture in which our people can thrive, develop and advance.
About Syneos Health Syneos Health (Nasdaq:SYNH) is a fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, strategically blending clinical development, medical affairs and commercial capabilities to address modern market realities.
Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialised. Here, each day brings an opportunity to take ownership of a new challenge. Teaming with some of the most talented clinicians in the industry, you'll improve patient outcomes and work in a dynamic environment to create better, smarter, faster ways to get biopharmaceutical therapies to patients. By joining Syneos Health, you'll be connected to our multitude of career paths and pipeline of employment opportunities.
WORK HERE MATTERS EVERYWHERE** | How will you accelerate improving patient outcomes?
- Syneos Health is an affirmative action/equal opportunity employer (Minorities/Females/Vet/Disabled)_
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