Join our global Pharmacovigilance team as a Deputy Regional Pharmacovigilance Lead. Position is remote, home-based in Romania.
Deputy Regional Pharmacovigilance Lead is responsible for supporting in compliance assurance with local and regional Quality Management System, management and oversight of personnel acting as LSO/MIS in dedicated region and evaluation of their work results and competence.
All CVs must be submitted in the English language for consideration.
Responsibilities:
- Act as Local Safety Officer/ deputy for standard and Local Safety Officer for complex Projects
- Act as local Medical Information specialist/deputy
- Line management of assigned pharmacovigilance team in a dedicated region
- Oversee assigned standard operating procedures/working practices
- Lead Biomapas Pharmacovigilance strategic initiatives
- Oversee local literature review process and responsible coordinating team
- Support Business Development and Contracts and Proposal team during RFI and RFP processes
- Participate in Biomapas bid defense meetings if necessary
- Participate in inspection and/or audits
- Oversee and manage financial payments for respective LSO/MIS in a dedicated region
- Support in overseeing LSO/MIS compliance and regularly report the results
- Support in staff recruitment process
Requirements
- Biologist, Pharmacist, Medical Doctor, or other life science degree
- At least 3-year experience with Local Pharmacovigilance activities
- Preferable experience to oversee a team or project management experience
- Excellent knowledge of international regulations (ICH, EU GVP Modules) and local pharmacovigilance specifics
- Fluent English and Romanian 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
Romania
