Medical Writer III, Pharmacovigilance

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

📋 Description

• Author, review, and ensure the quality of regulatory and pharmacovigilance documents, such as PSURs/PBRERs, PADERs, ACOs, DSURs, and Risk Management Plans.

• Confirm that documents are scientifically precise, regulatory compliant, and submitted within established timelines.

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

• Serve as a reliable point of contact for clients, aiding in project delivery and cultivating strong professional relationships.

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

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

⛳️ Requirements

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

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

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

• Ability to effectively train and mentor Associate Medical Writers.

• Strong team-oriented individual.

• Proficiency in English.

• Proficiency in an additional language is advantageous.

• A Master's or PhD is preferred.

🏝️ Benefits

• Employees have the option to work remotely.

• A culture of kindness, flexibility, growth, and belonging.

• A collaborative team environment.

• Opportunities for professional growth and development.

• Mentoring and knowledge-sharing opportunities are available.

• A passionate and collaborative team of experts.

• A diverse and inclusive workplace where every voice is valued.