Senior Medical Writer I (Line Management experience required) Lisboa

Overview

Senior Medical Writer I (Line Management experience required) role at Prime
Vigilance.

Prime
Vigilance (part of Ergomed Group) is a specialised
- size pharmacovigilance service provider established in 2008 with global presence. We offer services in Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.

Job Description

The Prime
Vigilance Senior Medical Writer role offers a unique opportunity to further develop your career in the field of drug safety. You will be working in an international team of experienced aggregate report writers, contributing to departmental growth.

Key Responsibilities

• Independent authoring, editing and reviewing of regulatory/clinical documents (e. g. aggregate reports, risk management plans and other documents needed throughout the product life cycle) with responsibility for quality and content, and compliance with internal and external standards
• Active participation in trainings and development, implementation and maintenance of quality system documents for medical writing, including internal templates and formats required for standardised documentation
• Support in all pharmacovigilance operations associated with medical writing
• Continuous
  - education in all aspects associated with medical writing
• Managing a team of junior medical writers

Qualifications

• Life Science degree – Ph
  D or Masters qualification is desirable
• Strong experience in full PV aggregate report writing (DSURs, PSURs, RMPs, ACOs, etc. )
• Previous experience in PV and working in a CRO/service provider environment
• Line Management Experience
• Excellent communication skills in English; additional languages desirable

Why Prime
Vigilance

We prioritise diversity, equity and inclusion by creating an equal opportunities workplace and a
- centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. We believe our people are our greatest strength in delivering
- quality client service.

Benefits

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunities to work with colleagues worldwide, with English as the company language

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Marketing, Public Relations, and Writing/Editing
• Industries: Pharmaceutical Manufacturing