Informacje o stanowisku

Pharmacovigilance Medical Writer II (Aggregate report writing experience required)

Join to apply for the Pharmacovigilance Medical Writer II (Aggregate report writing experience required) role at PrimeVigilance.

Company Description

PrimeVigilance (part of Ergomed PLC) is a specialised mid-size pharmacovigilance service provider established in 2008. We are global with staff across Europe, North America and Asia, covering Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.

PrimeVigilance provides first class support to our pharmaceutical and biotechnology partners, maintaining long-lasting relationships and becoming one of the global leaders in its fields. 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, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Job Description

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

• PSURs/PBRERs
• 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 (Aggregate report writing, 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

Why PrimeVigilance

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric 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. Our people are our greatest strength contributing to our continued success in improving lives.

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

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