Medical Writer III, Pharmacovigilance

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

📋 Description

• Create, evaluate, and perform quality checks on regulatory and pharmacovigilance documents, such as PSURs/PBRERs, PADERs, ACOs, DSURs, and Risk Management Plans.

• Ensure that documents are scientifically sound, comply with regulations, and are delivered within established timelines.

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

• Serve as a reliable point of contact for clients and assist in project delivery.

• Build and maintain strong working relationships with clients.

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

• Support the professional development and growth of Associate Medical Writers.

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

⛳️ Requirements

• MD, pharmacy, or Life Science degree.

• At least 2 years of experience in Medical Writing and related fields (case processing, signal detection, or risk management), preferably in a CRO setting.

• Capability to manage multiple tasks and prioritize workload with a keen attention to detail.

• Ability to effectively train and mentor Associate Medical Writers.

• Strong skills as a team player.

• Proficiency in English.

• Proficiency in an additional language is advantageous.

• Experience in regulatory and pharmacovigilance writing.

• Client-focused approach and meticulous attention to detail.

🏝️ Benefits

• Remote work option.

• Opportunities for professional growth and development.

• Mentoring and knowledge-sharing opportunities.

• Collaborative and supportive work environment.

• Flexible work culture.

• Inclusive workplace culture that fosters a sense of belonging.

• Opportunity to make a contribution to patient safety and global pharmaceutical initiatives.