Senior Medical Writer, Pharmacovigilance & Regulatory

PrimeVigilance Ltd.; Lisboa; Hybrid; EUR 38.000 - 62.000; Vollzeit

Zusammenfassung

PrimeVigilance Ltd. in Lisbon, Portugal, is seeking an experienced pharmacovigilance medical writer to join our expanding medical writing team.

You will author, review and quality-check regulatory and pharmacovigilance documents, mentor junior writers, and collaborate with cross-functional teams to interpret safety data for clients. We value accuracy, regulatory compliance, and timely delivery, with opportunities to grow within a global pharmacovigilance specialist.

Qualifikationen

• MD, pharmacy or Life Science degree required; advanced degrees desirable.
• Minimum 2 years' experience in Medical Writing and related fields (case processing, signal detection or risk management) ideally within a CRO.
• Ability to manage multiple tasks and prioritize workload.
• Ability to train and mentor Associate Medical Writers.
• Must be a strong team player.
• Fluency in English; an additional language is a benefit.

Aufgaben

• Author, review, and quality check regulatory and pharmacovigilance documents (PSURs/PBRERs, PADERs, ACOs, DSURs, RMPs).
• Ensure documents are scientifically accurate, regulatory compliant within 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.
• Provide guidance, mentoring, and knowledge sharing to junior medical writers.
• Contribute to process improvements and the continuous enhancement of medical writing quality standards.

Kenntnisse

Medical writing experience

Mentoring

Multitasking and prioritization

Team player

English fluency

Ausbildung

MD, pharmacy or Life Science degree

Masters or PhD desirable

Jobbeschreibung

PrimeVigilance Ltd. in Lisbon, Portugal, is seeking an experienced pharmacovigilance medical writer to join our expanding medical writing team.

You will author, review and quality-check regulatory and pharmacovigilance documents, mentor junior writers, and collaborate with cross-functional teams to interpret safety data for clients. We value accuracy, regulatory compliance, and timely delivery, with opportunities to grow within a global pharmacovigilance specialist.