Azurity Pharmaceuticals is hiring B. Pharma/ M. Pharma/ Pharma D as a Drug Safet
PHARMACY INDIA, May, MO, United States
Overview
Azurity Pharmaceuticals is hiring for a Drug Safety Associate (B. Pharma / M. Pharma / Pharma D) to support Pharmacovigilance activities across the organization. This role reports to the Director of Drug Safety and supports ongoing drug safety initiatives while maintaining compliance. Position
Drug Safety Associate Qualifications and Education
Bachelor’s or master’s degree in life science or healthcare-related field or equivalent combination of education and experience (i.e., an information science degree with at least 3 years of relevant working knowledge of supporting drug and patient safety) At least 3 years of experience reviewing individual case reports, aggregate reports and literature for adverse event reporting Strong analytic ability to analyze and summarize the main points of case reports, studies, and/or specific topics Experience with literature databases Excellent communication and organizational skills and the ability to work in a fast-paced environment Experience with safety databases Problem-solving skills regarding enforcing safety rules and global procedures as described in SOPs, Operational Manuals, and Guidance Documents Excellent written/oral communication skills with fluency in English Proactive behavior and ability to meet timelines High degree of responsibility and accountability and responsiveness Ability to develop cooperative working relationships with all levels of staff Conversant in medical terminology; MedDRA coding Proficiency with Adobe Acrobat and Microsoft Office (Word, Excel, PowerPoint) and related modules Working knowledge and understanding of FDA Regulations Responsibilities
Assist in maintaining compliance with Pharmacovigilance (PV) activities in accordance with company policies, SOPs, and FDA regulations Assist in safety agreement editing, renewal tracking, and formatting Assist with the management and oversight of safety-related information Assist with individual case review and management including company-sponsored clinical trials Assist with the management of the core drug safety email system Assist in managing and tracking reconciliations between partners Manage daily workflows and communications cross-functionally to ensure timely responses to partners Assist in the review, oversight, and organization of weekly and monthly safety reports Assist in organizing safety project management internal tools Assist in reviewing, organizing, and authoring standard operating procedures Assist in maintaining electronic files to ensure filing of applicable documents for audit readiness Assist in reviewing Expedited and Non-expedited safety reports and source documents for completeness and accuracy Contribute adverse event information for safety reports including PADERs and PSURs, as well as safety data for clinical reports Assist in maintaining pertinent workflows to increase the quality and submission of reports Assist in preparing and editing safety-related training materials Collaborate with other departments to ensure timely processing of reports Maintain the integrity of confidential information throughout the work process Physical & Mental Requirements
The physical demands described here are representative of those that must be met by an employee to perform the essential functions of this job. Reasonable accommodations may be made for individuals with disabilities. Must be able to sit for long periods of time Frequently stand, walk, sit, talk and/or hear Occasionally climb stairs and/or ride elevators Occasionally lift and/or move up to 25 pounds Manipulate keyboard, operate a telephone and hand-held devices Other miscellaneous job duties as required Job Location
Hyderabad Job Type
Full Time
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Azurity Pharmaceuticals is hiring for a Drug Safety Associate (B. Pharma / M. Pharma / Pharma D) to support Pharmacovigilance activities across the organization. This role reports to the Director of Drug Safety and supports ongoing drug safety initiatives while maintaining compliance. Position
Drug Safety Associate Qualifications and Education
Bachelor’s or master’s degree in life science or healthcare-related field or equivalent combination of education and experience (i.e., an information science degree with at least 3 years of relevant working knowledge of supporting drug and patient safety) At least 3 years of experience reviewing individual case reports, aggregate reports and literature for adverse event reporting Strong analytic ability to analyze and summarize the main points of case reports, studies, and/or specific topics Experience with literature databases Excellent communication and organizational skills and the ability to work in a fast-paced environment Experience with safety databases Problem-solving skills regarding enforcing safety rules and global procedures as described in SOPs, Operational Manuals, and Guidance Documents Excellent written/oral communication skills with fluency in English Proactive behavior and ability to meet timelines High degree of responsibility and accountability and responsiveness Ability to develop cooperative working relationships with all levels of staff Conversant in medical terminology; MedDRA coding Proficiency with Adobe Acrobat and Microsoft Office (Word, Excel, PowerPoint) and related modules Working knowledge and understanding of FDA Regulations Responsibilities
Assist in maintaining compliance with Pharmacovigilance (PV) activities in accordance with company policies, SOPs, and FDA regulations Assist in safety agreement editing, renewal tracking, and formatting Assist with the management and oversight of safety-related information Assist with individual case review and management including company-sponsored clinical trials Assist with the management of the core drug safety email system Assist in managing and tracking reconciliations between partners Manage daily workflows and communications cross-functionally to ensure timely responses to partners Assist in the review, oversight, and organization of weekly and monthly safety reports Assist in organizing safety project management internal tools Assist in reviewing, organizing, and authoring standard operating procedures Assist in maintaining electronic files to ensure filing of applicable documents for audit readiness Assist in reviewing Expedited and Non-expedited safety reports and source documents for completeness and accuracy Contribute adverse event information for safety reports including PADERs and PSURs, as well as safety data for clinical reports Assist in maintaining pertinent workflows to increase the quality and submission of reports Assist in preparing and editing safety-related training materials Collaborate with other departments to ensure timely processing of reports Maintain the integrity of confidential information throughout the work process Physical & Mental Requirements
The physical demands described here are representative of those that must be met by an employee to perform the essential functions of this job. Reasonable accommodations may be made for individuals with disabilities. Must be able to sit for long periods of time Frequently stand, walk, sit, talk and/or hear Occasionally climb stairs and/or ride elevators Occasionally lift and/or move up to 25 pounds Manipulate keyboard, operate a telephone and hand-held devices Other miscellaneous job duties as required Job Location
Hyderabad Job Type
Full Time
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