Amgen Hiring M Pharmacy Graduates | Pharmacovigilance Operations Associate Role
Looking for a Pharmacovigilance Job with a leading biotechnology company? Amgen Careers has announced an exciting opportunity for a Pharmacovigilance Operations Associate in Hyderabad. This Pharmacovigilance Job is ideal for candidates with experience in literature review, drug safety, and global pharmacovigilance who are looking to grow their careers through Amgen Careers.
- Job Title: Pharmacovigilance Operations Associate
- Location: Raj Bhavan, Karnataka, India
- Job ID: R-248109
About the Company
Amgen is one of the world’s leading biotechnology companies dedicated to discovering, developing, manufacturing, and delivering innovative human therapeutics. The company is committed to applying the highest ethical standards across its products, services, and communications while advancing healthcare through science and innovation.
Job Description
Amgen is hiring a Pharmacovigilance Operations Associate to support global literature surveillance activities across its product portfolio. The role is responsible for performing routine weekly reviews of literature articles retrieved from Embase, Medline, and BIOSIS databases to support signal detection and identify Individual Case Safety Reports (ICSRs) for marketed products.
The successful candidate will contribute to maintaining high-quality global literature surveillance processes while ensuring compliance with global pharmacovigilance regulations.
Key Responsibilities
Literature Management Process
- Perform a review of literature results retrieved and imported into the literature citation management system every week, and determine if the minimum criteria for ICSR are met for marketed products.
- Review 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 the 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.
- Ensure timely completion of weekly literature review activities.
- Maintain compliance with global pharmacovigilance requirements.
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
Knowledge and Skills
- 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
