Pharmacovigilance Associate performs routine PV tasks such as case intake, data entry, literature monitoring, and documentation management to support Local safety officers in the DACH region to maintain compliant PV operations, with further opportunity to be nominated as Local Safety Officer.
Position is remote/home-based in Germany.
All CVs must be submitted in the English language for consideration.
Responsibilities:- Perform routine and foundational PV activities for assigned projects (e.g., case intake, data entry, coding, literature monitoring, distribution of safety information)
- Perform initial case intake and triage according to SOPs
- Enter and code cases in safety databases with supervision
- Assist in follow-up activities (requests, tracking, documenting)
- Prepare cases for quality control review and correct findings promptly
- End to end case processing steps under supervision
- Assist with administrative tasks related to PV systems, including preparing files, templates, and checklists
- Provide administrative support for audits/inspections
- Conduct weekly literature searches using predefined search strategies
- Document search results, identify potential safety cases, and escalate to upper level for assessment
- Preparation of data for Aggregate Safety Reports (PSURs/PBRERs), RMP/SMP sections, and risk minimization activities
Requirements
- University degree (or final year student) in Life Sciences or a related field
- Fluent written and verbal English and German language
- Foundational knowledge of pharmacovigilance principles and relevant regulatory frameworks
- Ability to perform routine PV tasks (case intake, data entry, literature review) accurately under supervision
- Good computer literacy and ability to learn safety databases and PV systems
- Good organizational skills and ability to manage a routine workload effectively
- Strong attention to detail and accuracy in documentation
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
- University degree or final-year student status in Life Sciences or a related field
- Fluent written and verbal English
- Fluent written and verbal German
- Foundational knowledge of pharmacovigilance principles and relevant regulatory frameworks
- Ability to perform routine pharmacovigilance tasks accurately under supervision
- Computer literacy and ability to learn safety databases and pharmacovigilance systems
- Good organizational skills and ability to manage routine workloads
- Strong attention to detail and documentation accuracy
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
