Sr. Associate, Pharmacovigilance Operations
Sr. Associate, Pharmacovigilance Operations
Amgen
Job description
Looking to build a career in pharmacovigilance safety report writing? Explore this Sr. Associate, Pharmacovigilance Operations role at Amgen in Hyderabad.
Company Description
Amgen unlock the power of biology to help people who are dealing with serious illnesses. The company finds, creates, makes and provides treatments for humans by using tools such as advanced human genetics. Amgen focuses on areas where there is a need for better medical care using its strong experience in making biologics to make health results better. The company has been a leader in biotechnology since 1980. It has become one of the top independent biotech companies, in the world.
Job Summary
This role focuses on writing, compiling, and reviewing Amgen's Periodic Aggregate Safety Reports, based in Hyderabad. As a Sr. Associate, you will support reports such as DSUR, PBRER, PSUR, and country specific safety submissions. Your work will help make sure everything follows rules and that reports are done on time every time. You’ll also need to work with teams from areas and keep clear detailed records as you go. This is important, for staying on track and keeping everyone informed.
Key Responsibilities
Coordinate and schedule meetings with cross functional stakeholders for report alignment.
Collect PASR contributions from stakeholders and compile them into report templates.
Author safety content for PASRs alongside Therapeutic Area Safety scientists.
Conduct peer quality checks on authored safety sections.
Coordinate Amgen review, resolve comments, and initiate approval workflows.
Maintain records and documentation throughout the reporting process.
Review and approve published report versions across different regions.
Manage the distribution of reports to CROs and, to business partners.
Make sure that all reports meet the required deadlines follow the guidelines and match the style standards.
Do a peer review of PASRs by using the checklists.
Keep up to date with the regulatory guidelines, technology and industry standards.
Generate PASR metrics, including compliance and performance indicators.
Support literature management activities, as required.
Educational Qualification
A degree in life sciences, pharmacy, or a related field.
Skills Required
Strong experience in pharmacovigilance safety report writing.
Good understanding of global regulatory guidelines for safety reporting.
Strong coordination skills to work with cross functional teams.
Good documentation and quality review skills.
Strong written communication skills for scientific and regulatory content.
Ability to manage multiple report timelines and priorities.
Salary Structure
The salary for a Sr. Associate, Pharmacovigilance Operations at Amgen in India typically ranges from ₹10.6 Lakhs to ₹11.7 Lakhs per year.
Career Development
This role gives hands on experience in global pharmacovigilance reporting at a top biotechnology company. Amgen also backs term growth by offering mentorship, teamwork, across functions and chances to move up in safety and regulatory roles.
How to Apply
Visit our job portal and search for the Sr. Associate, Pharmacovigilance Operations role in Amgen.
Click on the job posting to read all the details about the job.
Fill in your details. Upload your updated resume.
Send your application.
Education
Bachelor's Degree
Key Skills
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