Pharmacovigilance Manager

We are looking for an Pharmacovigilance Manager, operating in Latvia, who will perform pharmacovigilance activities in Baltics States.

Duties and responsibilities:

• Write PV-related documents, e.g. PSURs, RMPs, PSMF.
• Literature monitoring to find safety data.
• Storage and archive of safety data, experience with PV database.
• Develop and write PV SOPs.
• Write safety data exchange agreements (SDEA).
• Regulatory intelligence in Baltics States.
• Manage and oversee all relevant maintenance activities potentially including Life Cycle Management strategy.
• Provide expert input to strategic decision making, including portfolio review, prioritization, and external communications.
• Ensure that quality standards are met and that the deliverables meet strict deadlines and fulfil all relevant expectations and quality standards

• Bachelor level degree required preferably in chemistry, biology or related life science.
• 3-5 years related work experience in Latvia, Estonia, and Lithuania in Pharmacovigilance.
• A clear understanding of European, international and local PV requirements including Good Pharmacovigilance Practices (GPvP)
• Strong interpersonal skills, ability to communicate and manage well at all levels of the organization and with staff at remote locations essential.
• High level of written and oral communication skills (Latvian, English and Russian).
• Ability to work independently and develop ideas and solutions to the department challenges and interface with regulatory bodies and consultants to resolve them.

• Work in internationally recognised and growing company.
• Competitive salary, starting from 1500 Euro to 2500 Euro per month (gross).
• Possibility to learn working with branches and different currencies.
• Opportunity to develop professional skills.
• Interesting, dynamic and responsible work.
• Working hours during working days from 9.00 to 18.00.
• Remote work mode from home office.