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Are you looking for Biotech Jobs, Amgen Careers, or Pharmacovigilance Jobs in Hyderabad? Amgen is hiring a Pharmacovigilance Operations Associate for its Hyderabad location. This exciting opportunity is ideal for life sciences and healthcare professionals with experience in literature review, drug safety, pharmacovigilance, and regulatory processes. Explore this latest Amgen Careers opening and take the next step in your biotechnology and pharmacovigilance career.
About Amgen
Amgen is a globally recognized biotechnology company focused on discovering, developing, manufacturing, and delivering innovative human therapeutics. Through advanced research and development, Amgen addresses serious illnesses and improves patient outcomes worldwide. The company offers excellent career opportunities for professionals seeking growth in Biotech Jobs, Pharmacovigilance Jobs, regulatory affairs, and drug safety operations.
Job Details
| Position | Pharmacovigilance Operations Associate |
| Company | Amgen |
| Location | Hyderabad, India |
| Job ID | R-248109 |
| Work Location Type | On Site |
| Category | Operations |
Key Responsibilities
- Perform a review of literature results retrieved and imported into the literature citation management system on a weekly basis, and determine if the minimum criteria for ICSR are met for marketed products.
- Perform a review of literature results to determine if the article contains new aggregate safety information in support of the periodic report and/or signal detection.
- Determine whether the full-text article needs to be ordered and order it if further information is needed to confirm if the citation meets criteria for ICSR or for signal detection.
- Flag articles containing new aggregate safety information for TA Safety to perform secondary review.
- Request the Local Safety Officer to provide an English translation if the article is not in English.
- Notify business partner of articles received, if applicable.
- Support audits and inspections.
Contribution
Ensures Amgen remains in compliance and maintains a high-quality global literature review process. Responsible for the timely completion of the review of weekly literature results.
Skills Needed
- Ability to identify literature articles containing ICSR criteria or aggregate safety findings supporting signal detection.
- Ability to order full-text articles where needed.
- Ability to receive feedback from Case Management and TA Safety, and optimize the quality of the literature review.
- Demonstrate knowledge of global aspects of pharmacovigilance.
- Strong knowledge of processes and global regulations for pharmacovigilance and literature surveillance.
- Ability to effectively manage competing priorities and timelines.
- Strong knowledge of literature citation management systems and platforms used to configure search strategies.
- Experience in the use of AI and prompts would be useful.
Qualifications
Basic Qualification
- Master’s degree and 1 year of pharmaceutical, biotech, or regulatory authority experience in a research and development setting.
- OR
- Bachelor’s degree and 1-2 years of Literature Screening/Review or relevant Safety experience.
Experience Required
Preferred Qualification & Experience
- Health Care/Life Science Professional with a minimum 2-3 years of relevant work experience, including 1 to 2 years of experience in literature review.
- Knowledge of bibliographic databases and direct literature review experience preferred.
Why Consider This Opportunity?
This role offers an excellent opportunity for professionals interested in Biotech Jobs, Amgen Careers, and Pharmacovigilance Jobs. Candidates will gain exposure to global literature surveillance, signal detection activities, ICSR identification, safety reporting processes, and international pharmacovigilance regulations while working with one of the world’s leading biotechnology organizations.
If you are seeking rewarding Biotech Jobs, exploring Amgen Careers, or looking to advance in Pharmacovigilance Jobs, the Pharmacovigilance Operations Associate position at Amgen Hyderabad could be an excellent career opportunity. Apply today and become part of a global team dedicated to advancing healthcare through innovation and patient safety.
