Pharmacovigilance Medical Writer III

Ergomed; Madrid; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

Join a leading company as a Pharmacovigilance Medical Writer. This role involves critical medical writing responsibilities, training opportunities, and participation in quality compliance efforts. Ideal candidates will have a strong background in Pharmacovigilance and a passion for contributing to patient welfare in a supportive, diverse environment.

Servicios

Training and career development opportunities

Strong emphasis on personal and professional growth

Friendly supportive working environment

Opportunity to work with global colleagues

Formación

• Strong experience in Pharmacovigilance within ideally a CRO environment.
• Ability to manage multiple tasks with attention to detail.
• Fluent in English; an additional language is a plus.

Responsabilidades

• Responsible for medical writing tasks including PADERs, and DSURs.
• Support project managers in scheduling aggregate reports.
• Train and mentor Associate Medical Writers.

Conocimientos

Clinical Research

Technical Writing

Writing Skills

FDA Regulations

Educación

MD pharmacy or Life Science degree

Masters or PhD (desirable)

Herramientas

Adobe Acrobat

Microsoft Powerpoint

Document Management Systems

Word Processing

Descripción del empleo

We are looking for a pharmacovigilance medical writer to join our team. The Medical Writer will be responsible for medical writing including :

• PADERs
• ACOs
• DSURs
• RMPs
• QC and review of all written output from the operations team as required
• Supporting the project managers to determine scheduling of the aggregate reports for which they are responsible
• In conjunction with the Quality Compliance and Training Manager identify areas for improvement and address via training clarifying changes to SOPs / OGs / templates
• Complete quality documentation of aggregate reports
• Attending kick off meetings with new clients as required
• Attending audits and inspections as required
• Providing aggregate report training

Qualifications :

• MD pharmacy or Life Science degree (Masters or PhD is desirable)
• Strong previous experience in Pharmacovigilance (case processing signal detection or risk management) within ideally 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

Additional Information :

Why PrimeVigilance

We prioritize diversity equity and inclusion by creating an equal opportunities workplace and a humancentric environment where people of all cultural backgrounds genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer :

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly supportive working environment
• Opportunity to work with colleagues based all over the world with English as the company language

Our core values are key to how we operate and if you feel they resonate with you then PrimeVigilance could be a great company to join!

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging

Come and join us in this exciting journey to make a positive impact in patients lives. We look forward to welcoming your application.

Remote Work : Employment Type :

Key Skills

Clinical Research,Adobe Acrobat,FDA Regulations,Technical Writing,Biotechnology,Clinical Development,Clinical Trials,Microsoft Powerpoint,Research Experience,Document Management Systems,Word Processing,Writing Skills

Experience : years

Vacancy : 1