Associate Director, Operational Analytics & Process Excellence - Drug Safety - Summit, NJ | Biospace
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Associate Director, Operational Analytics & Process Excellence - Drug Safety

Celgene

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Location:
Summit, NJ
Posted Date:
9/20/2017
Position Type:
Full time
Job Code:
17000527
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Description

Celgene
is a global biopharmaceutical company leading the way in medical innovation to
help patients live longer, better lives. Our purpose as a company is to
discover and develop therapies that will change the course of human
health.  We value our passion for patients, quest for innovation, spirit
of independence and love of challenge. With a presence in more than 70
countries - and growing - we look for talented people to grow our business,
advance our science and contribute to our unique culture.

The Associate Director, Operational Analytics & Process Excellence, resides within the Global Safety Operations group of Global Drug Safety & Risk Management (GDSRM) and is a global role based in Summit, NJ reporting to the Snr Director, Global Safety Operations.

The individual provides direct supervision to the Analytics & Process Excellence (APEX) team and is responsible for overseeing operational excellence including but not limited to, management and reporting of quality and compliance metrics across the Global Safety Network, provision of analyses and insights into the effectiveness of pharmacovigilance business processes, issue management (CAPA) and operationalization of pharmacovigilance. Additionally, this individual leads GDSRM participation in industry benchmarking activities used in the evaluation of pharmacovigilance policies, practices, strategies and effectiveness.

CORE RESPONSIBILITIES

Global Drug Safety & Risk Management (GDSRM)/Global Safety Network (GSN)Strategy

•Provide leadership and guidance to Safety Operations (APEX) Personnel in the execution of GDSRM process analytics and process    excellence (i.e. business intelligence) activities

•Lead project teams and coordinate activities required to implement GDSRM /GSN initiatives resulting from analytics and process    excellence outputs.

•Support management and prioritization of process improvement initiatives

•Act upon metrics based observations; identifying and supporting changes to processes

•Mentor and develop Safety Operations personnel responsible for process analytics and process excellence

•Provision of support and liaison to other functions

ICSR Quality & Compliance Management

•Provide trending of critical compliance and quality related issues (e.g. Late Case Investigations)

•Design and implementation of methodologies for root cause analysis of critical quality and compliance related issues such as Late Case    Investigations and erroneous reporting.

•Support regulatory inspections/audits through the generation of listings and analyses related to ICSR quality and compliance

•Ensure routine development and publication of quality and compliance activity reports for distribution to Global Safety Network (GSN)    stakeholders

•Contribute to the maintenance of the GDSRM Pharmacovigilance System Quality Manual and Master File.

•Oversee the implementation of requirements/commitments set out in pharmacovigilance agreements between Celgene and its partners,    ensuring Celgene remains compliant with all global pharmacovigilance regulations, company policies and procedures

•Oversee the execution of SDEA maintenance activities, which include but are not limited to data reconciliation and quality verification    activities

Contracts & Agreements

•Oversee the development and implementation of systems and technologies used for the maintenance and oversight of SDEA obligations    and contractual partner performance

•Oversee the production of global metrics and insights used to evaluate the quality, compliance and effectiveness of pharmacovigilance    contracts

•Execute root cause analysis and corrective actions for any identified non-compliance or areas of improvement.

Issue Management

•Oversee the tracking and management to closure of GDSRM issues and CAPA investigations and provide metrics for dissemination to GDSRM Senior Leadership and business process owners.

•Apply root cause analysis and problem solving methodologies during system audits and inspections to identify areas for corrective action and process improvements.

•Ensure Inspection readiness by providing detailed insights into areas of risk and approaches for mitigation, in collaboration with subject matter experts and business process owners.

•Represent Global Safety Operations as a Subject Matter Expert during inspections and audits

•Provide “back-room” support during inspections/audits, as required

Safety Data Quality

•Conduct impact analyses and deliver recommendations to the SDQC and where appropriate, the Data Entry Conventions Committee

•Oversee the provision of insights into data quality

Business Process Analytics

•Oversee the tracking and management of GDSRM key performance indicators (KPIs), which include but are not limited to quality and compliance metrics

•Implement KPI, Inspection readiness and quality & compliance dashboards used for the provision of analyses and insights into the effectiveness of pharmacovigilance business processes

•Enable the production of customized metrics and insights, outside of official metrics, as required by senior management

•Conduct continuous evaluation of emerging technologies that may improve departmental efficiency

•Assess and interpret the process impact of regulatory changes

•Propose future directions using innovative techniques derived from insights and understanding of process functioning

Benchmarking

•Oversee mechanisms and activities used to compare GDSRM pharmacovigilance activities against industry peers, in order to maintain detailed insight into;

Key business drivers, Strategic objectives, Technology strategies and tools, Cost and resource allocation

•Identify opportunities for improving performance

•Manage the process for annual industry benchmarking activities

Requirements

Qualifications

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none>•Master's
level degree (or Bachelor's Degree with relevant experience) in medical or life
sciences, or a combination of relevant education or professional experience

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none>•    Minimum
eight (8) years pharmaceutical/biotechnology drug safety experience preferred.

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none>•    Experience
of managing teams preferable

Technical

Quality  & Compliance / Analytics & Process Improvement

•Good understanding of the need for data accuracy, completeness, consistency and integrity.

•Ability to understand the implication of lack of compliance for regulated processes

•Appreciation of the link between medical services, quality assurance, customer service and drug safety

•Understanding of the application of six-sigma and other techniques and tools for process improvement

•Ability to lead complex, strategic projects (cross-functional, cross Business Unit/Shared Service Unit)

•Understanding of statistical techniques for data analysis

•Ability to draw out main messages from data, analysis and research, and identify essential supporting information.

Project Management

•Strong organizational and planning skills required including development and execution of project plans.

•Must have ability to work independently on multiple tasks

•Strong problem analysis and negotiation skills

Software Applications

•Experience with the use of the following software/applications types

Microsoft Office Suite, specifically Excel

SharePoint 2010 or above

SAP Business Objects, Oracle Business Intelligence (OBIEE) or similar preferred

Data visualization tools (e.g., QlikView, Spotfire or similar) preferred

Enterprise Document Management systems (e.g. Documentum or similar)

•Experience with Microsoft Project preferred

•Technical safety systems including ARISg or similar

Celgene is
committed to equal opportunity in the terms and conditions of employment for
all employees and job applicants without regard to race, color, religion, sex,
sexual orientation, age, gender identity or gender expression, national origin,
disability or veteran status.

Celgene complies
with all applicable national, state and local laws governing nondiscrimination
in employment as well as employment eligibility verification requirements of
the Immigration and Nationality Act. All applicants must have authorization to
work for Celgene in the U.S.