Pharmacovigilance Specialist is responsible for assuring compliance with local and regional Quality Management System and interact, exchange relevant safety and pharmacovigilance information.
Position is remote/home-based in Germany.
All CVs must be submitted in the English language for consideration.
Responsibilities:- Act as a PV contact/Local Safety Officer for DACH countries
- Communicate with Health Authorities and clients
- Ensure compliance with applicable local guidelines and regulation
- Collect, process, and reconcile about safety information
- Medical Information Requests handling
- Maintain and establish quality standards for local pharmacovigilance activities
- Ensure weekly monitoring of local literature review
- Participate in inspection and/or audits
- Ensure the survey and monitoring of national pharmacovigilance regulations
- Development and implementation of local standard operation procedures (SOPs)
- Creation and Provision of PV Training
Requirements
- Biologist, Pharmacist, Medical Doctor, or other life science degree
- 2-year experience in Local Pharmacovigilance activities in DACH region
- Fluent English and native German
- Computer literacy (MS Office), experience with PV databases
- Strong organizational and time management skills
- Ability to work independently and in a team
Benefits
- Professional growth and career opportunities
- International team and environment
- Bonus based on annual performance
- Personal accident and business trip insurance
- Additional health insurance
- Remote/home-based position
- Rewarding referral policy
- Workplace establishment allowance
- Team building, global meetings, B active events
Skills Required
- Degree in biology, pharmacy, medicine, or another life science discipline
- Two years of experience in local pharmacovigilance activities in the DACH region
- Fluent English
- Native German
- Computer literacy, including MS Office
- Experience with pharmacovigilance databases
- Strong organizational and time management skills
- Ability to work independently and as part of a team
What We Do
Biomapas is a functional and full outsourcing solution provider to the global life science industry. As a trusted partner for biopharmaceutical, medical device, cosmetics, and food supplement companies, we have one-stop-shop clinical research capabilities in high recruiting countries, delivering regulatory and pharmacovigilance excellence across Europe, CIS, MENA, and LATAM regions through the entire product lifecycle. Our in-house experience combined with a hands-on mindset allows for tailored solutions to complicated challenges that emerge on your path to commercialization. Our professionals execute your projects efficiently, cost-effectively and aspire to partner with you and become an integral part of your team from Early Development to Commercial success. We keep our promises. Always. Social media privacy policy: bit.ly/privacy-biomapas
