Manager Local Safety Units Processes

POSITION SUMMARY:

Establishing and implementing process harmonization (for assigned processes) among IPV local teams which simplify internal and contracted services (e.g., translation related to individual case safety reporting, due diligence methods, local literature review/ICSR identification, quality control steps, product quality complaint identification/handling, etc.). Is the lead to develop and implement a project team and plan with implementation check points/status reports. Proactively addresses barriers to implementation in partnership with team and regional leaders. Addresses or escalates issues that arise during implementation. Ensures implemented changes are meeting requirements and provides status reports to IPV CM LT. The person in this role will escalate barriers that cannot be addressed among the team. IPV CM Regional and Team Leaders have shared accountability for implementation of process alignments. Assignments will evolve and change as projects are delivered. Will collaborate with the AD LSU system/ Manager LSU System on procedural updates linked to system changes. Will support the CAPA Management team on CAPAs/QI related to the process of expertise.

PRINCIPAL RESPONSIBILITIES:

1. Subject Matter Expertise

Is a subject matter expert on the ICSR flow from inside and outside Janssen (all sources) through to the global safety database.

Is an SME on ICSR business partners (e.g., PQV, CQ, BQ, Call Centers, GMSO) and sustains relationships with same to understand dependencies and needs.

Becomes an SME on assigned proceses through self education, interviews/discussions, procedure review. Seeks to understand the landscape for a given process, can explain this in both simple and in-depth terms depending on the audience, proposes revised processes aligned with IPV CM and business partner needs and aligned with IPV CM strategy.

Provides personal expertise and project leadership.

2. Resource/Effort Calculation

Identifies a way to measure the effect of change/difference between LOC/LSU and applies that measurement to any changed process in order to evaluate success of implementation/unexpected affects to resources with process change.

Perform similar evaluation for process changes related to new/revised regulation (or develop tool for use by LSU to perform assessment).

3. Process Global Compliance Applicability

Ensures all new processes support local/regional regulations, addresses deviation memos/CAPAs.

Evaluate and document and obsolete processes no longer required, not meeting intended results or not aligned with IPV CM strategy.

4. Project Management

Executes projects and assignments. Serves as Project Leader for all assigned processes.

All process-related projects will be tracked for implementation, results, success determination and the Process Lead will own the oversight and reporting out on implementation status to IPV CM LT.

DECISION-MAKING AND PROBLEM-SOLVING:

The types of problems solved, decisions which are made, reviewed or referred are outlined in the principal responsibilities section.

REPORTING RELATIONSHIPS:

The Process Lead is an employee of International Pharmacovigilance within the Global Medical Organization (GMO).

The Process Lead has a direct reporting line to the Global IPV Head Process and Partners.

RESPONSIBILITY FOR OTHERS :

Exempt

WORKING RELATIONSHIPS/INTERFACES:

Internally: IPV Affairs, Local Case Management representatives, Case Management Team Leaders, Case Management Regional Leaders, GMSO functions, IPV Vendor Lead.

Externally local industry associations and Patient Advocacy groups, Local Business Partners, third Parties

Qualifications

Essential knowledge & skills

Proven ability to organize workflow activities and manage multiple critical issues.

Awareness of and familiarity with Janssen systems, procedures and requirements for individual case safety report management.

Computer literate with knowledge of relevant IT safety systems.

Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external customers.

Ability to establish and maintain open relationships within the organization.

Fluency in English language is required.

Project leadership or management (any size/scope).

Operational Excellence or FPX training is a plus.

Experience

Pharmacovigilance adverse event report handling, including mechanisms of intake, handling, literature, due diligence, product quality compliant, including systems, processes, and compliance oversight needs.

RELATED EXPERIENCE:

6 to 8 years

COMPARABLE POSITIONS:

Manager Case Management

Case Processing Manager