Pharmacovigilance Associate

This is a fully remote position, open to applicants in Germany.

📋 Description

• Execute routine and fundamental pharmacovigilance tasks for designated projects, encompassing case intake, data entry, coding, literature monitoring, and dissemination of safety information.

• Conduct initial case intake and triage in accordance with Standard Operating Procedures (SOPs).

• Enter and code cases in safety databases under supervision.

• Assist with follow-up inquiries, tracking, and documentation.

• Prepare cases for quality control assessments and promptly address any findings.

• Carry out end-to-end case processing steps with oversight.

• Aid in administrative duties related to pharmacovigilance systems, which includes preparing files, templates, and checklists.

• Provide administrative assistance for audits and inspections.

• Execute weekly literature searches utilizing predefined search strategies.

• Document search outcomes, identify potential safety cases, and escalate them for evaluation.

• Prepare data for Aggregate Safety Reports (PSURs/PBRERs), RMP/SMP sections, and risk minimization initiatives.

• Support Local Safety Officers in the DACH region to ensure compliant pharmacovigilance operations, with the possibility of advancement to Local Safety Officer.

⛳️ Requirements

• A university degree or status as a final-year student in Life Sciences or a related discipline.

• Proficient in both written and spoken English and German.

• Basic understanding of pharmacovigilance principles and pertinent regulatory frameworks.

• Capability to perform routine pharmacovigilance activities accurately under supervision, including case intake, data entry, and literature review.

• Competent computer skills and the ability to learn safety databases and pharmacovigilance systems.

• Strong organizational skills and the capacity to effectively manage a routine workload.

• Excellent attention to detail and precision in documentation.

• CV must be provided in English.

🏝️ Benefits

• Opportunities for professional growth and career advancement.

• Work within an international team and environment.

• Bonus based on annual performance.

• Personal accident and business trip insurance.

• Additional health insurance coverage.

• Position allows for remote or home-based work.

• Attractive referral policy.

• Workplace establishment allowance.

• Team building activities, global meetings, and B active events.