Local Safety Officer and Medical Information Specialist is responsible for managing daily operations, ensuring compliance, exchanging safety information and serving as a contact for timely safety processing.
Position is remote for the Nordic countries (Sweden, Norway or Denmark), working in close collaboration with Finland and Iceland local pharmacovigilance support personnel and acting as one contact point for our customers for all 5 countries.
Submit your CV in the English language for consideration.
Responsibilities:
- Perform local operations and ensure compliance with safety regulations and procedures
- Manage and share safety information with relevant authorities and clients
- Serve as the main contact for safety matters with authorities and clients
- Ensure timely handling of safety information for products
- Review local literature
- Medical Information Requests handling
Requirements
- Degree in Medicine, Biomedicine, Pharmacist or Nurse
- Fluent written and spoken English and at least one of the following languages: Swedish, Norwegian or Danish
- At least 2 years’ experience with Local pharmacovigilance activities in Nordics
- In-depth, demonstrated experience in most areas pertaining to pharmacovigilance and pharmacovigilance legislation
- Excellent knowledge of local and international regulations (ICH, EU GVP Modules)
- Analytical skills to understand, analyze, interpret, and present scientific data
- Ability to interpret and apply global and local drug safety regulations
- High motivation to develop and learn within the team
Benefits
- Professional growth and career opportunities
- International team and environment
- Bonus based on annual performance
- Personal accident and business trip insurance
- Influenza vaccines
- Rewarding referral policy
- Workplace establishment allowance
- Flexible working hours
- Team building, global meetings, B active events
Skills Required
- Degree in Medicine, Biomedicine, Pharmacist or Nurse
- Fluent in English and Swedish, Norwegian or Danish
- At least 2 years' experience in Local pharmacovigilance
- In-depth knowledge of pharmacovigilance legislation
- Excellent knowledge of local and international regulations
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
