The Regional Pharmacovigilance Lead is responsible for management and oversight of personnel acting as Local Safety Officers, Local QPPVs and Medical Information Specialist in the dedicated region which is mainly Western Europe and some other Non-Eu countries in MENA and APAC.
Position is remote, home-based in any European Union country.
All CVs must be submitted in the English language for consideration.
Responsibilities:
- Line management of assigned pharmacovigilance team in a dedicated region
- Ensure compliance with applicable local guidelines and high-quality local performance of countries in a dedicated region
- Oversee assigned standard operating procedures/working practices
- Monitor the workload and plan the required resources in a dedicated region
- Support Business Development and Contracts and Proposal team during RFI and RFP processes
- Participate in Biomapas bid defense meetings organized by potential customers
- Support Biomapas personnel in audits/inspections preparation
- Initiate request for new LSO/MIS needs and participate in selection process
- Support in staff recruitment process
- Oversee and manage financial payments for respective LSO/MIS in a dedicated region
Requirements
- Biologist, Pharmacist, Medical Doctor, or other life science degree
- At least 3-years experience with Local Pharmacovigilance activities
- Experience with team oversight and line management
- Excellent knowledge of international regulations (ICH, EU GVP Modules) and local pharmacovigilance specifics
- Fluent English and resident country language
- Strong communication and relationship building skills
- Proactive problem-solving approach
- Strong organizational and time management skills
- Excellence in accurate and diligent working
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
- Influenza vaccines
- Rewarding referral policy
- Workplace establishment allowance
- Team building, global meetings, B active events
- Workcation possibility
Top Skills
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.
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