Sr. Associate - Pharmacovigilance Operations (Amgen, Hyderabad)

🌟 Now Hiring: Sr. Associate, Pharmacovigilance Operations at Amgen, Hyderabad! 🌟



Are you a highly meticulous and experienced pharmacovigilance professional looking for your next challenge? Amgen, a global leader in biotechnology, is seeking a Sr. Associate, Pharmacovigilance Operations to join their vital team in Hyderabad!

This is a fantastic opportunity to play a crucial role in ensuring patient safety by contributing to essential regulatory reporting processes.

What You'll Do: Safeguarding Patients Through Expert Reporting 📝

As a Sr. Associate, Pharmacovigilance Operations, you'll be at the heart of authoring, compiling, and peer-reviewing Amgen's Periodic Aggregate Safety Reports (PASRs). Your work directly supports compliance with global regulatory requirements and ensures timely submissions.

Here's a closer look at your key responsibilities:
 * PASR Compilation & Authoring: You'll coordinate and schedule meetings with diverse cross-functional teams, drive report timelines, and expertly author safety content for various PASRs (like DSURs, PBRERs/PSURs, PADERs, etc.) in collaboration with Therapeutic Area Safety scientists.
 * Quality & Collaboration: You'll conduct thorough peer QC of safety sections, manage Amgen's review processes, resolve comments, and initiate approval workflows. Collaboration with internal stakeholders and external business partners is key to collecting all necessary contributions.
 * Documentation & Compliance: Maintaining meticulous records, ensuring adherence to established timelines, regulatory guidelines, and internal standards is paramount. You'll also review and approve published report versions and manage their distribution.
 * Continuous Improvement: Staying current with regulatory guidelines, technological advances, and industry standards is essential. You'll also contribute by generating PASR metrics, including Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs).
 * Literature Management: You may also assist with literature management activities as needed.
Who We're Looking For: Your Expertise Matters ✨

To thrive in this role, you'll need:
 * Experience: A Master's degree OR a Bachelor's degree with at least 5 years of relevant experience.

 * Meticulous Attention to Detail: Essential for ensuring accuracy and compliance in all reports.
 * Strong Collaboration Skills: The ability to work effectively with cross-functional teams and external partners.
 * Regulatory Knowledge: A solid understanding of global regulatory requirements related to pharmacovigilance reporting.
 * Time Management: The capability to drive timelines and manage multiple tasks efficiently.
Why Amgen? Pursue Progress, Discover Extraordinary. 🚀

Working at Amgen means being part of a global biotechnology company dedicated to unleashing the potential of biology for patients suffering from serious diseases. You'll contribute to a mission that impacts lives, surrounded by innovative thinkers and a supportive environment.

This on-site position in Hyderabad, India, offers a chance to build a significant career in drug safety within a world-class organization.

Ready to advance your career in pharmacovigilance?

 * Location: Hyderabad, India (On-Site)
 * Career Category: Safety
 * Job Requisition ID: R-219472


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