Pharmacovigilance Jobs in Hyderabad

Job Description: Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality and countries. The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, post market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams Basic Qualifications: Master s degree OR Bachelor s degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Associate s degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR High school diploma / GED and 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms Qualification : Bachelors degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Join Amgen s Mission of Serving Patients At Amgen, you re part of something bigger our shared mission to serve patients with serious illnesses drives everything we do. Since 1980, we ve been pioneers in the biotech industry, focusing on Oncology, Inflammation, General Medicine, and Rare Diseases, helping millions of patients live longer, fuller lives. Amgen remains on the cutting edge of innovation, combining biology and technology with human genetic data to push beyond what s possible today. Specialist IS Engineer What You ll Do As a Specialist IS Engineer, you will develop and implement the next generation of pharmacovigilance platforms while supporting existing technologies. This includes designing, developing, and deploying complex software solutions while mentoring junior developers. You ll collaborate with cross-functional teams to deliver high-quality, scalable solutions that ensure system reliability and innovation in safety systems. Key Responsibilities Design, develop, and deploy solutions for pharmacovigilance systems to enhance adverse event intake and distribution. Ensure technical implementation aligns with GxP validation processes and IS Change Control standards. Collaborate with partners to prioritize system enhancements and new functionalities for safety systems. Develop innovative solutions using Generative AI and large language models (LLMs) like OpenAI GPT for improved decision-making and efficiency. Rapidly prototype and translate concepts into working code. Drive automation and process improvements within the drug-safety ecosystem. Conduct code reviews and maintain technical documentation for architecture, design, deployment, and disaster recovery. Lead technical root cause analyses and collaborate with software vendors to resolve system-related issues. Basic Qualifications Master s Degree with 4 6 years of experience, or Bachelor s Degree with 6 8 years of experience, or Diploma with 10 12 years of experience in Computer Science, Software Development, or a related field Required Skills Must-Have: Proficiency in SQL, Databricks, and data modeling concepts Experience in Python or JavaScript and reporting tools like Power BI or Tableau Familiarity with PV terminologies and regulatory compliance Hands-on experience with SDLC, ETL tools (Informatica, Databricks), and API integrations (MuleSoft) Strong problem-solving skills, collaborative mindset, and effective communication Knowledge of ITIL processes and GxP validation Nice-to-Have: Experience with COTS Pharmacovigilance Platforms (e.g., Argus) Cloud experience with AWS or Azure Knowledge of AI, Machine Learning (ML), Natural Language Processing (NLP) Professional certifications such as SAFe Agile Software Engineer or SAFe for Teams Soft Skills Strong verbal and written communication skills Analytical and problem-solving mindset Ability to collaborate with global, virtual teams Initiative-driven with an ownership mindset Adaptability and resilience in ambiguous situations What You Can Expect Amgen offers a collaborative, science-driven culture and comprehensive benefits, including competitive salaries, professional growth support, and a focus on your well-being. Shift Information: This role may require working late shifts, with potential for evening or night schedules based on business needs. Apply now to make a real difference in the lives of patients while transforming your career at careers.amgen.com. Equal Opportunity Employer: Amgen is committed to creating a diverse and inclusive environment. We provide reasonable accommodations to individuals with disabilities.

Join Amgen s Mission of Serving Patients At Amgen, you ll be part of something bigger driven by our shared mission to serve patients with serious illnesses. Since 1980, we ve been pioneering biotech innovations, focusing on oncology, inflammation, general medicine, and rare disease.Join us to help make a lasting impact on patients lives while transforming your career. Case Management QA Vendor Associate What You Will Do: As a Case Management QA Vendor Associate, you will play a vital role in ensuring the quality and compliance of global case intake and processing activities. You will oversee vendors, manage case quality, and ensure adherence to regulatory requirements while supporting inspections, audits, and continuous improvement initiatives. Key Responsibilities: Monitor and ensure vendors deliver high-quality Individual Case Safety Reports (ICSRs) that meet global regulatory standards. Act as the US/EU local safety office and primary FDA/EMA point of contact for safety reporting. Provide training and resources to vendors to maintain compliance and quality. Perform quality control reviews, trend analysis, and generate reports on case quality. Manage vendor case processing timelines for adverse event intake, triage, and submission. Support inspections, audits, and CAPA (Corrective and Preventive Action) activities. Assist in Periodic Aggregate Safety Reports (PASR) processes and maintain a state of inspection readiness. Collaborate with local safety offices and attend vendor management meetings. Analyze QC trends and recommend improvements. Support onboarding and offboarding of vendor staff. What We Expect of You Basic Qualifications: Bachelor s degree with 3 years of related experience, or Associate s degree with 5 years of related experience, or High school diploma/GED with 7 years of related experience Previous experience in managing teams, projects, or resource allocation Preferred Skills: Knowledge of global pharmacovigilance regulatory requirements Proficiency in safety case processing and experience with global safety databases Strong communication skills, attention to detail, and experience supporting audits/inspections Proficiency in Microsoft Word, Excel, PowerPoint, Project, and Outlook What You Can Expect from Us Amgen is committed to supporting your professional growth and well-being with a collaborative, science-driven culture and a competitive Total Rewards Plan aligned with industry standards. Equal Opportunity Amgen is an Equal Opportunity Employer and embraces diversity. We provide reasonable accommodations for individuals with disabilities throughout the application process.