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Pfizer
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Aggregate Report Analyst Senior Associate

Aggregate Report Analyst Senior Associate

Pfizer

2 - 6 years

0 Lacs

chennai tamil nadu

Posted:1 month ago| Platform: Shine logo

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Skills Required

writing skills interpersonal skills analytic skills regulatory knowledge

Work Mode

On-site

Job Type

Full Time

Job Description

The PSSR Aggregate Report Analyst is responsible for creating documents related to post-marketing safety data to assist in product development, license application, and post-marketing maintenance in collaboration with project teams. These documents involve integrated analyses of safety data supporting aggregate reports, responses to regulatory inquiries, post-marketing safety assessments, and Risk Management Plans among others. You must accurately interpret regulatory requirements and corporate policies to ensure timely and compliant analyses and presentations of safety data. Your primary responsibilities include communicating resource and timeline needs for assigned documents, ensuring compliance with internal SOPs and external regulatory guidance, driving document strategies in collaboration with project team experts, delivering documents on time, overseeing the work of other authors when necessary, and collaborating with external vendors. You should also understand the relationships between different documents produced for regulators and collaborate with quality lines to ensure accuracy and quality. To qualify for this role, you should possess a Bachelor's Degree in life sciences and at least 2 years of relevant medical experience, such as patient care, clinical trial experience, academic medicine, specialty training, or pharmaceutical industry experience. An advanced degree (MD, DVM, PharmD, or Masters/PhD) in a relevant field is preferred. Additionally, you should have the ability to execute routine analyses, interpret safety data, understand regulatory guidance, synthesize analyses into written text, and make decisions to resolve complex problems. Pfizer is an equal opportunity employer that complies with all applicable equal employment opportunity legislation in each jurisdiction where it operates.,

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Aggregate Report Analyst Senior Associate