Medical Writer III, Pharmacovigilance

This is a fully remote position, open to applicants in Bosnia and Herzegovina.

📋 Description

• Author, review, and conduct quality checks on regulatory and pharmacovigilance documents, such as PSURs/PBRERs, PADERs, ACOs, DSURs, and Risk Management Plans.

• Ensure that documents are scientifically accurate, adhere to regulatory compliance, and are delivered within established timelines.

• Collaborate with cross-functional teams to analyze, interpret, and present safety data effectively.

• Serve as a reliable client contact, supporting project delivery and nurturing strong working relationships.

• Guide, mentor, and impart knowledge to junior medical writers.

• Contribute to process enhancements and the elevation of medical writing quality standards.

⛳️ Requirements

• MD, pharmacy, or a degree in Life Sciences.

• A minimum of 2 years' experience in Medical Writing and related fields, including case processing, signal detection, or risk management.

• Experience, preferably within a CRO environment.

• Ability to handle multiple diverse tasks and prioritize workload with meticulous attention to detail.

• Capability to effectively train and mentor Associate Medical Writers.

• Strong team player.

• Proficiency in English.

• Proficiency in an additional language is advantageous.

• A Master's or PhD is preferred.

🏝️ Benefits

• Option for remote work.

• Flexible work environment.

• Opportunities for growth and professional development.

• Mentoring and knowledge-sharing opportunities.

• Collaborative team atmosphere.

• Chance to contribute to process improvements.

• Opportunity to engage in global pharmacovigilance and clinical research projects.