- 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.