Are you passionate about pharmacovigilance, regulatory submissions, and safety data analysis? Pfizer, a global leader in pharmaceuticals, is hiring an Aggregate Report Analyst Manager in Chennai, India. This role is ideal for professionals with experience in post-marketing safety, clinical trial reporting, or regulatory documentation who want to advance their career in global safety and regulatory writing.
Key Responsibilities
As an Aggregate Report Analyst Manager at Pfizer, you will:
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- Prepare aggregate safety documents such as DSURs, PBRERs, PSURs, RMPs, ACOs, and regulatory safety responses.
- Ensure compliance with internal SOPs and international regulatory guidance.
- Collaborate with cross-functional teams and provide oversight to co-authors or vendors.
- Translate safety data into clear, factual, and concise documents for regulatory submissions.
- Act as a point of contact for assigned products and drive document strategies.
- Support process improvement initiatives within Worldwide Safety (WWS).
Required Qualifications
- Education:
- Bachelor’s degree in Life Sciences with 3+ years’ relevant medical/pharma experience.
- Advanced degree (MD, PharmD, PhD, MSc) preferred.
- Experience & Skills:
- Strong knowledge of pharmacovigilance and regulatory reporting requirements.
- Experience in patient care, clinical trials, safety, or regulatory roles.
- Analytical skills to interpret safety data and synthesize into reports.
- Excellent scientific writing and communication abilities.
- Ability to manage timelines and deliver high-quality regulatory documents.
Why Join Pfizer?
- Opportunity to work on global regulatory submissions and contribute to drug safety worldwide.
- Collaborative and inclusive work culture.
- Professional growth in pharmacovigilance and regulatory affairs.
- Competitive compensation and benefits package.
Application Process
