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Manager, Drug Safety Aggregate Reporting

Expired Job

Endo Pharmaceuticals Malvern , PA 19355

Posted 4 months ago

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.

POSITION SUMMARY:

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

REQUIRED QUALIFICATIONS:

  • 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)

PHYSICAL REQUIREMENTS:

Office environment

Endo recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities.

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

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VIEW JOBS 11/9/2018 12:00:00 AM 2019-02-07T00:00 Job Description Job Title Drug Safety Associate, Aggregate Reporting Company Endo Function Research and Development Location(s) Malvern, PA Department Pharmacovigilance Direct Reports (list) N/A Reports to (title) Manager, Aggregate Reporting Date Submitted 9/4/2018 To be completed by Corporate Compensation: Job Code Band Date Reviewed 9/7/2018 Benchmark EEO FLSA (USA only) Exempt Job Summary - a concise overview of the job Develop and author 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. Manage the scheduling and workflow of aggregate reports through the established Company process. Perform database searches, generate and analyze reports to make sure all appropriate cases are placed in the report as per the regulatory requirements. All incumbents are responsible for following applicable Division & Company policies and procedures. Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc. 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). Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time Accountability Responsibilities % of Time Aggregate Reports * 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 80% Process Improvement * Participate on cross functional, multidisciplinary teams and contribute to defining aggregate reporting guidelines * Partner with Case Processing, Quality/Compliance and Safety Systems staff to ensure efficient and compliance aggregate reporting processes 20% Total 100% Qualifications Education & Experience Minimal acceptable level of education, work experience and certifications required for the job * Bachelor's Degree in life sciences, pharmacy, nursing (RN, RPh) or combination of Health Related Degree and clinical experience in a medical setting * Four (4) years of experience in pharmaceutical drug safety/pharmacovigilance including experience in preparation of aggregate safety reports Knowledge Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. * 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 generation and analysis of aggregate report data listings * In-depth understanding of the aggregate reporting process * Experience preparing and finalizing documents in Word and Adobe Skills & Abilities Often referred to as "competencies", leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc. * Highly organized, analytical, and logical in approach to all assigned tasks * Strong project management skills. Ability to manage multiple priorities. * Excellent interpersonal, oral and written communication skills * Skilled in Microsoft Office applications (Word, PowerPoint, Excel) Physical Requirements Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc. * Office environment Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Page 1 of 2 Customer Focus - Breakthrough Thinking – Collaboration – Accountability Endo Job Description Template - Revised July 2012 Endo Pharmaceuticals Malvern PA

Manager, Drug Safety Aggregate Reporting

Expired Job

Endo Pharmaceuticals