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Medical Writer III (Pharmacovigilance)

Ergomed

УдалённоПолная занятость

Также открыта в Madrid

О вакансии

Ergomed is seeking a skilled Medical Writer III specializing in pharmacovigilance to enhance their medical writing team in a remote capacity. The role involves authoring, reviewing, and ensuring the quality of various regulatory documents, such as PSURs, PBRERs, and Risk Management Plans. Candidates should possess a strong background in regulatory writing, with a focus on accuracy and compliance, while also being able to manage multiple tasks effectively. A minimum of two years of experience in medical writing or related fields is required, ideally within a contract research organization (CRO). A degree in medicine, pharmacy, or life sciences is necessary, with advanced degrees being advantageous. Fluency in English is essential, and knowledge of an additional language is a plus. The position is well-suited for motivated individuals who enjoy mentoring junior writers and collaborating with cross-functional teams to improve writing quality standards. This role is ideal for those who thrive in a team-oriented environment and are passionate about contributing to the pharmaceutical industry.

Текст объявления

We are looking for an experienced pharmacovigilance medical writer to join our growing medical writing team. What We're Looking For: A highly motivated and detail-oriented medical writer who combines strong regulatory writing expertise with a client-focused mindset and a passion for developing others. You will play a key role in delivering high-quality regulatory documents, strengthening client relationships, and supporting the growth of the wider team. The Medical Writer will be responsible for medical writing including: Key Responsibilities: Author, review, and quality check a range of regulatory and pharmacovigilance documents, including: PSURs/PBRERs PADERs ACOs DSURs Risk Management Plans (RMPs) Ensure documents are scientifically accurate, regulatory compliant, and delivered within agreed timelines. Collaborate with cross-functional teams to analyse, interpret, and present safety data effectively. Act as a trusted point of contact for clients, supporting project delivery and fostering strong working relationships. Provide guidance, mentoring, and knowledge sharing to junior medical writers to support their professional growth and development. Contribute to process improvements and the continuous enhancement of medical writing quality standards. MD, pharmacy or Life Science degree (Masters or PhD is desirable) Minimum 2 years' experience in Medical Writing and associated fields (case processing, signal detection or risk management) ideally within a CRO environment Ability to manage multiple and varied tasks and prioritize workload with attention to detail Ability to effectively train and mentor Associate Medical Writers Must be a strong team player Fluency in English, an additional language is a benefit When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting. We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here. Quality: we hold ourselves to the standard patients deserve. Integrity and trust: we do the right thing, especially when it is hard. Drive and passion: we care about the outcome, because someone is waiting on it. Agility and responsiveness: we move quickly, because patients cannot wait. Belonging: everyone is welcome, and every voice counts. Collaborative partnerships: we go further by going together. We look forward to welcoming your application.

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