Aggregate Report Analyst Manager

Position: Aggregate Report Analyst Manager

Location: Chennai, Tamil Nadu (Hybrid)

Level: Mid-Level

Industry: Pharmaceutical • Biotech • Healthtech • AI • Machine Learning • NLP

Role Overview:

As an Aggregate Report Analyst Manager, you will lead the development of global post-marketing safety and regulatory documents. You’ll ensure content accuracy, regulatory compliance, and timely delivery, while coordinating with internal teams and external vendors. This role blends scientific writing, data analysis, and regulatory expertise to support Pfizer’s commitment to drug safety and patient care.

Key Responsibilities:

• Document Development:
• Create and manage documents such as PSURs, DSURs, PBRERs, RMPs, and Safety Update Reports that support global regulatory submissions and product safety evaluation.
• Cross-functional Collaboration:
• Work with safety, regulatory, clinical, and quality assurance teams to gather data and ensure scientific integrity and compliance.
• Oversight & Vendor Management:
• Guide internal or external co-authors and review vendor-produced reports. Provide feedback and assess vendor performance.
• Project Leadership:
• Define timelines and resource requirements, manage risks, and proactively communicate issues to project teams and leadership.
• Content Strategy:
• Translate complex safety data into concise, compliant, and impactful regulatory documents with clear benefit-risk narratives.
• Process Improvement:
• Identify opportunities for process efficiency and propose improvements to documentation workflows and cross-team collaboration.

Requirements:

Education:

• Bachelor’s degree in life sciences with 3+ years of relevant experience in pharmacovigilance, safety writing, clinical development, or regulatory affairs.
• Advanced degree (MD, PharmD, PhD, or Master’s in a related field) preferred.

Experience:

• Strong background in post-marketing regulatory documentation and safety reporting.
• Familiarity with ICH, EMA, FDA guidelines related to pharmacovigilance and aggregate safety reporting.
• Experience leading cross-functional teams and handling multiple concurrent projects.

Key Skills:

• Scientific and regulatory writing (e.g., DSUR, PBRER, RMP)
• Strong analytical and decision-making skills
• Knowledge of global regulatory requirements for safety documents
• Excellent communication and stakeholder management
• MS Office Suite proficiency
• Ability to translate medical and safety data into clear regulatory documents

Why Join Pfizer:

• Work on life-changing therapies that impact patients worldwide
• Collaborate with top-tier professionals in regulatory science and pharmacovigilance
• Contribute to a mission-driven company that values integrity, innovation, and inclusivity
• Enjoy robust professional development opportunities and global exposure