Manager, Drug Safety Aggregate Reporting Pharmacovigilance R&D Malvern, PA
About Endo International plc
Endo International plc (NASDAQ: ENDP) is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com.
Responsible for managing the development and authoring of aggregate reports including Periodic Adverse Drug Experience Reports (PADERs), Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs) for all clinical and marketed products. Responsible to recruit, hire, train, mentor and manage aggregate report staff. Manages the scheduling and workflow of aggregate reports through the established Company process. Performs database searches, generates and analyzes reports to make sure all appropriate cases are placed in report as per the regulatory requirements.
Responsible to ensure timely, consistent and accurate development of aggregate reports in accordance with ICH & FDA guidelines, applicable regulatory requirements, Good Clinical Practices (GCPs) and standard operating procedures (SOPs). Responsible for managing and mentoring aggregate reporting team staff.
ROLE AND RESPONSIBILITIES:
Develop and author aggregate reports for all products
Manage scheduling and workflow of aggregate reports through established company processes
Perform database searches and analyze listings to ensure data are appropriately and accurately reflected in all aggregate reports
Perform quality review of report and data listings to verify report layout/format and data accuracy
Manage the aggregate report review process and maintain close contact with Regulatory Affairs to ensure timely submission to FDA
Recruit, hire, train, mentor and manage a team of professionals who perform aggregate reporting activities
Monitor and manage staff workload to ensure on time completion and submission of aggregate reports
Oversee day to day activities of team including QC of aggregate reports prepared by team as needed, resolve issues and escalate to management, as needed
Participate on cross functional, multidisciplinary teams and contribute to defining aggregate reporting and safety data management guidelines
Partner with Case Processing, Quality/Compliance and Safety Systems management to ensure efficient and compliance aggregate reporting processes
Bachelor's Degree in a relevant scientific field with Health Related Degree (RN, PharmD) and clinical experience in a medical setting. Advanced Degree preferred.
Eight (8) years of experience in pharmaceutical drug safety/pharmacovigilance including aggregate reporting experience. Staff management and case processing experience is highly desired.
Extensive working knowledge of FDA regulations, FDA guidance and ICH guidance; some familiarity exposure to EMEA regulations
High level of computer literacy, particularly in the use and management of Drug Safety databases and generation and analysis of aggregate report data listings
In-depth understanding of the ICSR assessment and reporting process
Experience preparing and finalizing documents in Word and Adobe
Highly organized, analytical, and logical in approach to all assigned tasks
Strong leadership & project management skills. Ability to manage multiple priorities and manage resources to drive completion.
Excellent interpersonal, oral and written communication skills
Ability to provide coaching, guidance, and feedback to help others excel on the job and meet key accountabilities
Skilled in Microsoft Office applications (Word, PowerPoint, Excel)
Endo recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled