Drug Safety Associate

Azurity Pharmaceuticals

3+ years

Not Disclosed

Hyderabad

15 June 12, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

The Medical Affairs Group at Azurity is hiring a highly motivated Drug Safety Associate to join the team. This individual will report to the Director of Drug Safety and will support Pharmacovigilance activities across the organization. This individual will leverage existing industry knowledge, organizational and communication skills to support ongoing drug safety initiatives while maintaining compliance.

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 the filing of applicable documents to ensure audit readiness
Assist in reviewing Expedited and Non-expedited safety reports and source documents including review for completeness and accuracy
Contribute adverse event information for safety reports including Periodic Adverse Drug Experience Reports (PADERs), Post-Marketing Periodic Safety Update Reports (PSURs) as well as safety data for clinical reports
Assist in maintaining pertinent workflows to increase the quality and submission of reports
Assist in the preparation and editing safety related training materials
Collaborate with other departments to ensure the timely processing of reports
Maintains the integrity of confidential information throughout the work process

Qualifications and Education Requirements

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
Possess experience with literature databases
Possess excellent communication and organizational skills and the ability to work in a fast-paced environment
Possess experience with safety databases
Problem-solving skills, especially with respect to enforcing safety rules and global procedures as described in SOPs, Operational Manuals, and Guidance Documents
Excellent written/oral communication skills are essential including fluency in English
Proactive behavior and ability to keep 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
Maintains comprehensive proficiencies with Adobe Acrobat and Microsoft Office (e.g., Word, Excel, and PowerPoint) and associated modules
Capable of working in a team-oriented and rapidly changing environment
Possess a working knowledge and an understanding of FDA Regulations

Physical & Mental Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Must be able to sit for long periods of time
While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
May occasionally climb stairs and/or ride elevators
The employee must occasionally lift and/or move up to 25 pounds
Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
Other miscellaneous job duties as required

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