Local Safety Officer Germany (m/f/x) | Munich | Pharma
The company is one of the 20 largest pharmaceutical companies in the world and operates in 16 European countries. With over 15,000 employees in 20 countries, the company develops and markets innovative medicines for patients in the field of hypertension, thrombotic diseases and in the field of oncology.
What will your tasks as EU Qualified Person be?
- Responsible for performing/overseeing all local PV activities in Germany
- Performs/oversees local literature screening, monitoring of local PV legislation and implementation of Risk Management Plans (RMPs) and additional Risk Minimization Measures
- Be accountable for managing other DSE/DSDE stakeholders (e.g. Marketing) as well as local PV vendors, and providing PV Training to relevant local functions
- Support the EU Pharmacovigilance System Master File (EU-PSMF) through the provision of up-to-date information from the local PV system
- Supports EU affiliate management activities out of DSE CSPV as EU Headquarters as a member of EU affiliate management team
- Facilitates the local implementation of global processes (e.g. management of the collection of adverse events, PV regulatory intelligence, management of Safety Data Exchange Agreements (SDEAs))
- Implement/maintain PV agreements/SDEAs with local partners/PV service providers working with internal subject matter experts (SMEs) ensuring all PV requirements are covered in the contract
- Contributes to the enhancement of EU affiliates PV Quality Management System standards by providing the inputs from local PV system in Germany
Your requirements as "Local Safety Officer Germany (m/f/x)"?
- Degree in Medicine, Pharmacy, or natural sciences
- Significant experience in pharmacovigilance
- Strong knowledge of internationals regulations and standards safety monitoring and post-marketing
- Ability to understand complex matters with a continuous focus on improvement
- Proactive, autonomous, and reliable working style paired with the ability to work in international matrix teams
- Consistent attention to details
- German and English: fluent in spoken and written
They will offer you?
- Unlimited contract with permanent position
- Up to 75 % Remote
- attractive benefits package
My contact details:
- Email: firstname.lastname@example.org
- Tel: 0049 (0) 89/26 20 09 25 (direct dial)
- Xing: https://www.xing.com/profile/Marlene_Inderhees/cv
- LinkedIn: https://www.linkedin.com/in/marlene-inderhees-376a7a16b/
Are you interested in this position? Then you should apply now! If you would like to receive further or alternative positions, I would also be happy to receive your application!
I look forward to your application!