Manager, Case Management - Ireland
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Posted on : 08 June 2017
The Manager, Case Management is responsible for line management and leading the team responsible for executing the collection, triage, E2B acceptance and processing of adverse event data in compliance with applicable FDA and global regulations and our company standard operating procedures and guidelines. Responsibilities include but are not limited to:
- Provides coaching and mentoring to staff on a daily basis
- Completes relevant HR activities such as timeoff requests, job description review, performance management activities ensuring all employees have clear goals, objectives and development plans, performance review discussions, etc.
- Ensures team execution of case management activities ensuring that the submissions and reconciliation team can submit cases to regulatory authorities and business partners’ ontime.
- May perform case management operational activities during periods of peak workload or to support business continuity.
- Directly responsible for the daily activities of the global case management team who perform ICSR case management activities
- Manages team/personnel in daily activities include overseeing performance management, staff development plans and execution of those plans; coaching and mentoring staff to deliver high quality while meeting regulatory timelines.
- Recruits and facilitates the onboarding of staff, collaborating with Learning and Development to ensure appropriate training is assigned
- Identifies product leads and backup product leads to ensure business continuity
- Identifies resource needs and allocations to ensure appropriate function of the team.
- Manages daily workload for the team to ensure timely completion of data entry, triage, E2B acceptance (and failures) and case processing, ensuring that submission and reconciliation can achieve a high level of reporting compliance to health authorities and business partners
- Closely collaborates with the Global Case Management Leader, Vendor
- Management team, and the Submissions & Reconciliation team to ensure high quality and compliance of case management activities across internal teams and the case management vendor
- Collaborates with medical reviewers to ensure that medical review and documentation is provided for assigned cases
- Collaborates with the Agreements and Compliance team to support the investigation of root cause for late individual case safety reports, including implementing corrective and preventive actions, if appropriate.
- Manages the maintenance of the coding conventions and collaborates with the safety data management team to ensure safety database configurations are accurate
- Participates in the review of regulatory intelligence to identify any changes to case management activities.
- As appropriate collaborates with the process, SOP and training team to make necessary internal procedural changes.
- Acts as a liaison with internal departments and external business partners on case management issues
- Performs other activities as directed by department management
- Experience leading people or teams. Global experience; including working across time zones is preferred.
- Strong knowledge of FDA and international adverse event reporting regulations per ICH guidelines and the ability to interpret and apply applicable regulations to resolve issues
- Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations.
- Proficiency in standard desktop software programs (Word, Excel,
- PowerPoint, Outlook).
- Must have an excellent understanding of global Pharmacovigilance regulations
- Familiarity with aggregate safety reporting, signal detection and pharmacovigilance processes a plus.
- Must have experience working with Oracle (Relsys) Argus.
- Experience with preparation of investigational reports, postmarketingregulatory reports and transmission of E2B reports is required
- Must be self-motivated, detail oriented and ability to multitask.
- Must possess excellent communication (oral and written) and complex problem solving skills.
- Must have strong interpersonal/organizational skills.
- Must be able to manage their own work, with ability to prioritize, plan and organize work assignments while working under strict timelines
- Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required
- Must possess the ability to work in a team environment and follow written policies/procedures.
- Must be comfortable in a fast=paced, demanding work environment.
- Flexibility to work outside of normal working hours or on-call arrangements.
Required/Preferred Education and Licenses
- BS/BA degree in a health related (e.g., RN/BSN, RPh/PharmD) or biological science related field or a combination of non-degree education and 10+ years of industry experience 8+ years PV, regulatory or compliance related experience
- Minimum 1+ years people management (direct reports) experience or 2+ years of leading project teams (no formal direct reports but responsible for team deliverables)
Description of Physical Demands
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands
Our company is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender-identity, national origin, disability status, protected veteran status, or any characteristic protected by law.