Manager, Drug Safety Case Processing

Why Endo?

We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.

Job Description Summary

Responsible for oversight and management of Individual Case Safety Report (ICSR) processing for marketed and investigational products across all case types including spontaneous, clinical trial and litigation. Responsible for oversight of case processing vendor including training and mentoring of vendor case processing staff. Guide vendor on resource scheduling and workflow to ensure that case processing activities from receipt through submission are carried out in accordance with relevant regulatory requirements and established company processes. Perform Quality Control (QC) activities related to case processing. Serve as subject matter expert (SME) related to case processing and assist in the development of safety surveillance processes and writing corresponding SOPs.

Job Description

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.

Responsible to ensure timely, consistent and accurate case processing and safety reporting in accordance with ICH 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

Individual Case Safety Report (ICSR) Processing

• Oversee end-to-end ICSR processing for all products (i.e., marketed, investigational, branded and generic) and all case types including spontaneous, clinical trial and litigation.

• Monitor workload and workflows to ensure on time submissions to regulatory authorities and partners

• Guide vendor staff on day-to-day ICSR processing activities including mailbox management registration, triage, entry, QC, medical review, submission and follow-up activities are carried out in accordance with relevant regulatory requirements and established company processes

• Triage and resolve case processing issues and escalate to management, as needed

• Perform quality review of ICSRs and provide feedback to vendor, as needed.

40%

Oversight, Mentoring & Training of Vendor Staff

• Oversee end-to-end ICSR processing for all products

• Serve as primary point of contact for vendor on all aspects related to ICSR processing

• Train and mentor vendor staff in processing of ICSRs

40%

Process Improvement

• Participate on cross functional, multidisciplinary teams and contribute to defining case processing guidelines

• Partner with Case Processing, Quality/Compliance and Safety Systems management to ensure efficient and compliance case processing.

• Assist in the development of safety surveillance processes and writing corresponding SOPs

• Co-author / co-develop data entry process instructions and update accordingly when processes and procedures change

• Perform quality review of ICSRs to identify and resolve process issues

• Develops follow-up processes (letters, questionnaires and phone contact) to obtain relevant medical information pertinent to case analysis and signal detection

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, PharmD) or combination of Health Related Degree and clinical experience in a medical setting. Advanced Degree preferred.

• Eight (8) years of experience in pharmaceutical drug safety/pharmacovigilance case processing including branded and generic products and all case types (spontaneous, clinical trial and litigation).

• Experience in triaging of cases, coding of terms using MedDRA, data entry and narrative writing.

• Vendor oversight experience highly desired.

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 use and management of Drug Safety databases including ICSR data entry, regulatory reporting, and data querying

• In-depth understanding of the ICSR assessment and reporting process

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 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

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

Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person's unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.

EEO Statement:

At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.