Pfizer Jobs at Chennai | Apply for Aggregate Report Analyst Manager Role at Pfizer Careers Now!
Pfizer is seeking an experienced Aggregate Report Analyst Manager in Chennai to create and review post-marketing safety documents. This Aggregate Report Analyst Manager role involves analyzing safety data, supporting regulatory submissions, and collaborating with global project teams to ensure timely, accurate, and compliant reporting. It is ideal for life sciences professionals with experience in safety, regulatory, or clinical domains.
Job Description:
- Location: Chennai, India
- Job Type: Full-Time
- Posted On: 10 Days Ago
- Job Requisition ID: 4938857
- Position Purpose: Responsible for creating documents related to post-marketing safety data, supporting product development, license applications, and post-marketing maintenance. This includes DSURs, PSURs, PBRERs, Addenda to Clinical Overviews, and other regulatory submissions.
About the Pfizer:
Pfizer is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines. With a commitment to improving health worldwide, Pfizer empowers its employees to make a meaningful impact in healthcare and regulatory compliance.
Aggregate Report Analyst Manager Role Overview:
The PSSR Aggregate Report Analyst Manager is responsible for creating documents related to post-marketing safety data to support product development, license application, and post-marketing maintenance. This role involves collaborating with project teams to produce various reports and responses to regulatory queries.
Educational Requirements for the Aggregate Report Analyst Manager Role:
- Bachelor’s Degree in Life Sciences with 3+ years’ relevant medical experience (patient care, clinical trials, academic medicine, or pharmaceutical industry experience).
- Advanced degrees preferred (MD, DVM, PharmD, or Master’s/PhD in a relevant field).
Key Responsibilities for the Aggregate Report Analyst Manager Role:
- Communicate resource and timeline needs for assigned documents to project teams.
- Ensure timely production of documents in compliance with internal SOPs and external regulatory guidance.
- Drive document strategies collaboratively with project team experts.
- Oversee internal and external authors to maintain quality and accuracy.
- Produce and review documents in collaboration with external vendors.
- Understand dependencies across regulatory documents (RMPs, DSURs, PBRERs, ACOs).
- Collaborate with quality lines and project teams for accuracy and compliance.
- Act as point of contact for document issues for assigned products if designated.
- Identify and propose process improvements to line management.
Skills Required for the Aggregate Report Analyst Manager Role:
- Ability to execute and interpret routine safety analyses.
- Comprehensive regulatory knowledge on benefit/risk communication and pharmacovigilance.
- Strong writing skills for synthesizing analyses into clear documentation.
- Understanding of disease pathology and treatment approaches.
- Analytical and decision-making skills for moderately complex problems.
How to Apply for Pfizer Jobs?
Interested candidates can apply online via Pfizer careers portal. Keep your resume and relevant documents ready for submission.
