Pharmacovigilance Medical Writer II (Aggregate report writing experience required) Lisboa

Pharmacovigilance Medical Writer II (Aggregate report writing experience required)
Lisboa
Lisboa, Lisboa, Portugal

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 Prime
Vigilance

Pharmacovigilance Medical Writer II (Aggregate report writing experience required)

20 hours ago Be among the first 25 applicants

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

Company Description

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

Company Description

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

Prime
Vigilance provides first class support to our small to large 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,
- 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
- 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 Ph
  D 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
  
  

Additional Information

Why Prime
Vigilance

We prioritize 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.

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 Prime
Vigilance could be a great company to join!

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

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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Marketing, Public Relations, and Writing/Editing

• Industries

  Pharmaceutical Manufacturing

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Vigilance by 2x

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