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Systems Specialist (Argus)

Pharmaceutical Product Development (PPD)

CA-San Francisco

PPD has an exciting opportunity for a Systems Specialist (Argus), to join us onsite exclusively for one of our strategic partners in San Francisco, CA. PPD works in collaboration with this pharmaceutical partner; you will be dedicated to the client projects, processes, working within their teams and systems on behalf of PPD. You should ideally be based in San Francisco, CA and be open to travelling to their office a few times per week/work from their offices on a full-time basis.

Key responsibilities:

Proactively collaborates with initiative leads and senior management to prepare, organize, coordinate, document and/or provide the development and delivery of department products and services to a globally dispersed, cross-functional audience in support of business outcomes and industry compliance requirements. Extensive knowledge of the Argus application and database. Resolve incidents and perform Argus troubleshooting (L1). Perform User Account Maintenance. Argus Console maintenance, including study configuration, code list management, field validations, ICSR checks, reporting destination maintenance, etc. Report monitoring/management. Generate ad hoc Oracle SQL queries. Provides guidance and reviews or creates varied support materials, presentations, and/or tools to support department's remit and strategies. Proactively collaborates with initiative leads and senior management to develop, optimize and improve processes, associated systems/applications, training and communications. Leads large scale, complex process improvement initiatives. Skillfully develops process improvement processes and solutions. Proactively identifies and collates information required to assess compliance with processes and to prioritize business process improvement needs. May review, assess and update procedural documents for overall compliance with current processes. Performs special projects, assignments and administrative tasks per business needs. Mentors, coaches, and supports team members in developing and implementing process improvement initiatives. Proactively collaborates with initiative leads and senior management to prepare, organize, coordinate, document and/or provide the development and delivery of department products and services to a globally dispersed, cross-functional audience in support of business outcomes and industry compliance requirements. Provides guidance and reviews or creates varied support materials, presentations, and/or tools to support department's remit and strategies. Proactively collaborates with initiative leads and senior management to develop, optimize and improve processes, associated systems/applications, training and communications. Leads large scale, complex process improvement initiatives. Skillfully develops process improvement processes and solutions. Proactively identifies and collates information required to assess compliance with processes and to prioritize business process improvement needs. May review, assess and update procedural documents for overall compliance with current processes. Performs special projects, assignments and administrative tasks per business needs. Mentors, coaches, and supports team members in developing and implementing process improvement initiatives.

PPD has an exciting opportunity for a Systems Specialist (Argus), to join us onsite exclusively for one of our strategic partners in San Francisco, CA. PPD works in collaboration with this pharmaceutical partner; you will be dedicated to the client projects, processes, working within their teams and systems on behalf of PPD. You should ideally be based in San Francisco, CA and be open to travelling to their office a few times per week/work from their offices on a full-time basis.

Key responsibilities:

Proactively collaborates with initiative leads and senior management to prepare, organize, coordinate, document and/or provide the development and delivery of department products and services to a globally dispersed, cross-functional audience in support of business outcomes and industry compliance requirements. Extensive knowledge of the Argus application and database. Resolve incidents and perform Argus troubleshooting (L1). Perform User Account Maintenance. Argus Console maintenance, including study configuration, code list management, field validations, ICSR checks, reporting destination maintenance, etc. Report monitoring/management. Generate ad hoc Oracle SQL queries. Provides guidance and reviews or creates varied support materials, presentations, and/or tools to support department's remit and strategies. Proactively collaborates with initiative leads and senior management to develop, optimize and improve processes, associated systems/applications, training and communications. Leads large scale, complex process improvement initiatives. Skillfully develops process improvement processes and solutions. Proactively identifies and collates information required to assess compliance with processes and to prioritize business process improvement needs. May review, assess and update procedural documents for overall compliance with current processes. Performs special projects, assignments and administrative tasks per business needs. Mentors, coaches, and supports team members in developing and implementing process improvement initiatives. Proactively collaborates with initiative leads and senior management to prepare, organize, coordinate, document and/or provide the development and delivery of department products and services to a globally dispersed, cross-functional audience in support of business outcomes and industry compliance requirements. Provides guidance and reviews or creates varied support materials, presentations, and/or tools to support department's remit and strategies. Proactively collaborates with initiative leads and senior management to develop, optimize and improve processes, associated systems/applications, training and communications. Leads large scale, complex process improvement initiatives. Skillfully develops process improvement processes and solutions. Proactively identifies and collates information required to assess compliance with processes and to prioritize business process improvement needs. May review, assess and update procedural documents for overall compliance with current processes. Performs special projects, assignments and administrative tasks per business needs. Mentors, coaches, and supports team members in developing and implementing process improvement initiatives.

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years).

Knowledge, Skills and Abilities:

Knowledge of MedDRA and WHODrug dictionaries.

Custom development (updates).

Strong knowledge of PV regulations, systems and processes (Argus, Cognos etc.)

Proven PV operations expertise (Case Management; CSRT etc.), particularly in understanding PV QMS needs related to safety reporting and regulations to balance the existing expertise in the group

Ability to translate business needs and priorities into processes and systems requirements

Good Project management skills to support/lead process improvement initiatives

Experience with root cause analysis, process optimization and change management

Computer literate with the ability to work within multiple databases

Proficient in Microsoft Office products (including Outlook, Word, and Excel)

Thorough understanding of the global regulatory requirements and the importance of and compliancewith procedural documents and regulations

Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision

Strong attention to detail

Ability to maintain a positive and professional demeanor in challenging circumstances

Ability to work effectively within a team to attain a shared goal

#LI-PA1

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years).

Knowledge, Skills and Abilities:

Knowledge of MedDRA and WHODrug dictionaries.

Custom development (updates).

Strong knowledge of PV regulations, systems and processes (Argus, Cognos etc.)

Proven PV operations expertise (Case Management; CSRT etc.), particularly in understanding PV QMS needs related to safety reporting and regulations to balance the existing expertise in the group

Ability to translate business needs and priorities into processes and systems requirements

Good Project management skills to support/lead process improvement initiatives

Experience with root cause analysis, process optimization and change management

Computer literate with the ability to work within multiple databases

Proficient in Microsoft Office products (including Outlook, Word, and Excel)

Thorough understanding of the global regulatory requirements and the importance of and compliancewith procedural documents and regulations

Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision

Strong attention to detail

Ability to maintain a positive and professional demeanor in challenging circumstances

Ability to work effectively within a team to attain a shared goal

#LI-PA1

Job posted: 2020-11-24

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