Pharmacovigilance Specialist - Germany, Hessen

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 also maintain the locally needed standardised practices to ensure compliance with international and national regulations. 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
• Responsible for PV interface with local health authorities
• Prepare and conduct Pharmacovigilance (PV) training for our customer’s local employees and non-PV staff including external service providers
• Support bridging the local-to-global and global-to-local 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 cross-functional 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

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we take into consideration transferrable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.

• Bachelor or Academic degree in life science.
• Experience in pharmacovigilance (post-marketing and clinical trials)
• Good knowledge of local and European PV regulations
• Fluent in spoken and written German and English
• Good understanding of data

Interviews may be conducted in person at an on-site interview location. For any in-person interviews, local Covid safety guidelines will be followed.

At Syneos Health, we believe in providing an environment and culture in which our people can thrive, develop and advance. We reward and recognise our people by providing valuable benefits and a quality of life balance.

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.

To learn more about how we are Shortening the distance from lab to life^®, visit syneoshealth.com or subscribe to our podcast.

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.

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Syneos Health is an affirmative action/equal opportunity employer (Minorities/Females/Vet/Disabled)