Medical Writer III, Pharmacovigilance

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

📋 Description

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

• Ensure that documents maintain scientific accuracy, comply with regulations, and are completed within established timelines.

• Work collaboratively with cross-functional teams to analyze, interpret, and present safety data.

• Serve as a reliable client contact, aiding in project delivery and nurturing professional relationships.

• Offer guidance, mentorship, and knowledge sharing to junior medical writers.

• Contribute to the enhancement of medical writing quality standards and process improvements.

⛳️ Requirements

• MD, pharmacy, or Life Science degree.

• At least 2 years of experience in Medical Writing and related areas (such as case processing, signal detection, or risk management).

• Preferably, experience within a CRO environment.

• Capability to handle multiple and diverse tasks while prioritizing workload with meticulous attention to detail.

• Proficient in training and mentoring Associate Medical Writers.

• Strong ability to work effectively within a team.

• Proficiency in English.

• Knowledge of an additional language is advantageous.

• A Master's or PhD is preferable.

🏝️ Benefits

• Option for remote work.

• Flexible working environment.

• Opportunities for growth and professional development.

• Mentoring and knowledge-sharing initiatives.

• A collaborative team environment.

• A workplace culture that emphasizes belonging.