
Senior Pharmaceutical Safety Document Specialist
1 week ago
This job is an exciting opportunity to work with a leading pharmaceutical company. We are seeking a skilled professional to join our team as an Aggregate Report Analyst.
- The successful candidate will create documents related to post-marketing safety data, supporting product development, license application, and post-marketing maintenance.
- They will accurately translate regulatory requirements and corporate policies into timely and compliant analyses and presentations of safety data.
Main Responsibilities:
- To communicate project needs to the team and negotiate resource allocation.
- To ensure assigned documents meet relevant internal SOPs and external regulatory guidance.
- To drive document strategies and messages in collaboration with project teams.
Requirements:
- Bachelor's Degree in Life Sciences or related field, with 3+ years of relevant experience.
- Advanced degree preferred (MD, DVM, PharmD, or Master's/PhD in relevant field).
- Strong analytical skills, comprehensive knowledge of regulatory guidance, and excellent writing abilities.
We offer a competitive compensation package and opportunities for career growth and development.
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