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Puma Biotechnology, Inc. is in search of a Pharmacovigilance Associate. This role is a full-time position that requires a professional equipped with 1-2 years of pharmacovigilance experience. The primary focus of this position is to support case processing activities and ensure compliance with global regulatory requirements. The individual will be responsible for various aspects related to the intake and processing of Individual Case Safety Reports (ICSRs).
The responsibilities of a Pharmacovigilance Associate encompass a range of tasks to uphold the standards in safety operations. These include:
Processing adverse events (AE) and special situation cases, which involves intake, triage, data entry, follow-up, narrative writing, coding, and conducting quality reviews in the safety database.
Performing medical coding using standardized codes from MedDRA and WHO Drug, as well as supporting dictionary upgrades and conducting quality checks when necessary.
Ensuring timely regulatory reporting, which entails assessing the seriousness, expectedness, and reportability of cases according to established procedures.
Conducting case quality control (QC), resolving data discrepancies, and ensuring documentation is inspection-ready.
Engaging in operational metrics tracking to identify trends and propose process improvements, contributing to the overall effectiveness of the department.
Collaborating with various departments including Clinical Operations, Medical Affairs, and Regulatory, ensuring a seamless flow of information and consistent safety data management.
Supporting inspections and audits by maintaining accurate documentation and responding to inquiries from regulatory bodies.
To be considered for this role, candidates must have:
1-2 years of relevant experience in drug safety or pharmacovigilance, particularly with ICSR case processing.
Proficiency in the use of safety databases, demonstrating a comprehensive understanding of end-to-end case workflow.
Knowledge of global PV regulations and guidelines, particularly ICH E2A, E2B(R3), E2D, and FDA/EMA reporting norms.
Experience with medical coding and strong attention to detail.
Excellent written and verbal communication skills, with the ability to summarize case findings accurately.
A Bachelor’s degree in life sciences, pharmacy, nursing, public health, or a comparable field is required.
Preferred qualifications include:
Experience with safety data reconciliation and knowledge of safety reporting gateways.
A background of interaction with vendors or CROs and familiarity with audits and inspections.
The position requires an effective work ethic as it is carried out in a professional virtual environment. Employees are expected to work primarily from home but may need to adjust hours based on global case processing requirements. The working hours are generally Monday through Friday from 8:30 AM to 5 PM, with possible variations based on business needs. Occasional travel, up to 5%, may be required for meetings or conferences, but the role mainly operates remotely.
The salary range for the Pharmacovigilance Associate role is between $70,000 and $85,000 annually. Candidates with advanced skills or extensive experience may be eligible for higher compensation. In addition to a competitive salary, employees will receive:
An annual bonus target.
A comprehensive benefits package, which may include health insurance, retirement plans, and other perks.
Puma Biotechnology is an equal-opportunity employer and values diversity in its workforce. All qualified applicants will have equal consideration for employment without regard to protected characteristics.
This role presents a robust opportunity for individuals looking to advance their careers in pharmacovigilance. The position not only demands a proactive approach to managing safety data but also fosters collaboration across various functions to enhance drug safety reporting. With competitive compensation and support for continuous learning, joining the team at Puma Biotechnology could significantly benefit your professional trajectory in this field.
This job offer was originally published on remoteOK.com
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