Senior Medical Writer (Pharmacovigilance aggregate reports)- Homebased in Europe Lisboa

Senior Medical Writer (Pharmacovigilance aggregate reports)- Homebased in Europe
Lisboa
Lisboa, Lisboa, Portugal

Company Description

We are Prime
Vigilance (part of Ergomed Group), a specialised
- size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America, and Asia covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

Prime
Vigilance provides
- class support to our pharmaceutical and biotechnology partners, maintaining
- lasting relationships and becoming one of the global leaders in its field. We cover all therapy areas, including medical devices.

We love investing in our staff by providing an excellent training and development platform. We value employee experience,
- being, and mental health, acknowledging that a healthy
- life balance is critical for employee satisfaction, nurturing an environment for
- quality client service.

Come and join us in this exciting journey to make a positive impact on patients’ lives.

Job Description

The Prime
Vigilance Senior Medical Writer position offers a unique opportunity to further develop your career in the field of drug safety.

Key Responsibilities

1. Independent authoring, editing, and reviewing of various regulatory/clinical documents (e. g. , aggregate reports, risk management plans, and other documents needed throughout the product’s life cycle), ensuring quality and compliance with internal and external standards.
2. Active participation in training and development, implementation, and maintenance of quality system documents for medical writing, including internal templates and formats required for standardized documentation.
3. Support in all pharmacovigilance operations associated with medical writing.
4. Continuous
   - education in all aspects associated with medical writing.
5. Managing a team of junior medical writers.

1. Previous experience in pharmacovigilance medical writing, including PBRERs, DSURs, and RMPs writing.
2. Previous line management experience.
3. Life Science degree or equivalent nursing or medical qualifications.
4. Ability to manage multiple and varied tasks and prioritize workload with attention to detail.
5. Ability to effectively train and mentor Associate Medical Writers.
6. Advanced knowledge of English.

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

1. Quality
2. Integrity & Trust
3. Drive & Passion
4. Agility & Responsiveness
5. Belonging
6. Collaborative Partnerships