Safety Writer Ii

1 week ago

Gurgaon, India PPD Full time

PPD’s mission, as part of Thermo Fisher Scientific is to improve health. It starts as an idea to cure. It becomes a life saved. All in-between, it’s you We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.

This is a great opportunity for experienced Safety Writers currently working within the life science sector for pharmaceutical companies, biotech companies or Clinical Research Organizations (CROs), to work for a global leading CRO.

As the trusted partner of some of the most innovative big pharma and biotech companies; our Safety Writers have the opportunity to work on challenging projects across a wide range of therapeutic areas. Our vision is to be the global leader in our industry; based on consistent quality and execution, exceptional customer-aligned service and constant innovation.

You should have significant scientific or medical writing experience, thrive in project teams and be focused on delivering exemplary levels of customer service. Capable of concise and clear written and verbal communication; you will be able to understand, interpret, analyze and present complex data and have a high attention to detail. As you may be working on multiple reports at the same time, you should have strong organizational skills, including the ability to prioritize work to ensure that strict timelines are adhered to. You must be comfortable with having direct interaction with clients, as you will be responsible for running meetings and managing review and comment resolution stages of document preparation.

In return we will offer you a positive and supportive working environment within one of the most engaged teams in the industry; who are recognized as the cornerstone of our success. We will provide you with the opportunity to acquire valuable personal and professional skills.
- Bachelor’s or higher scientific degree.
- Excellent English - both written and verbal.
- Advanced knowledge of Microsoft Office package.
- Task based project management experience and experience with interacting directly with clients.
- Good understanding and knowledge of aggregate safety report writing guidelines, and clinical trial and post-marketing pharmacovigilance.
- Experience of authoring device aggregate safety reports or clinical evaluation reports is preferable, although not essential.
- Must have a minimum of two years’ experience in authoring two or more of the following report/document types for medicinal products:

- DSURs (Development Safety Update Reports)
- PBRERs / PSURs (Periodic Benefit Risk Evaluation Reports / Periodic Safety Update Reports)
- PA(D)ERs (Periodic Adverse [Drug] Experience Reports)
- RMPs (Risk Management Plans)

PPD is now part of Thermo Fisher Scientific. As the world leader in serving science, our Mission is to enable our customers to make the world healthier, cleaner and safer. We are excited about the opportunities this combination brings to enhance our comprehensive end-to-end offering, enabling customers to move rapidly from scientific idea to approved medicine.
Integrity - Innovation - Intensity - Involvement

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