Job Details: Senior Safety Project Lead - Pharmacovigilance


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Senior Safety Project Lead - Pharmacovigilance
IQVIA? is the leading human data science company focused on helping
healthcare clients find unparalleled insights and better solutions for
patients. Formed through the merger of IMS Health and Quintiles, IQVIA
offers a broad range of solutions that harness the power of healthcare
data, domain expertise, transformative technology, and advanced
analytics to drive healthcare forward.

The RoleManages the delivery of lifecycle safety scope from pre-award,
project initiation / transition to closeout.

Ensures quality deliverables are presented on time and within budget;
coordinates work streams and efforts of cross-functional project teams
while monitoring the use of consistent tools and methodologies;
identifies and evaluates potential project risks and develops
mitigation plans; and serves as the primary point of contact with the
project customer.

Job Overview

Responsible for management and service delivery excellence for
assigned projects, covering single or multiple Lifecycle Safety
functions (clinical trial and / or post-market). Provide leadership
and accountability for customer-facing activities and oversight of
operational service delivery, working cross-functionally and across
the opportunity lifecycle, integrating delivery into one seamless and
transparent program for customers, aligned by accounts. Collaborate
with global management team and integrated partners to develop and
implement strategic initiatives/solutions to expand business,
partnership, strengthen overall relationship and ensure global
consistency.

Responsibilities

Manage customer interface and communication for assigned projects.
Represent Lifecycle Safety on projects and serve as primary point of
contact within Lifecycle Safety for all internal and external
customers; liaise between internal/external customers and Lifecycle
Safety Operational teams.

Manage customer deliverables for assigned projects and bring
continuity to project design and delivery through customer delivery.
Tactical, day-to-day customer-facing leadership at project level.

_RESPONSIBILITIES_ include project planning (timelines, deliverables),
defining project/scope management, quality management and project
financial management.

May act as an account owner over a program or customer portfolio and
therefore report program/portfolio level metrics and provide oversight
of projects they do not directly lead. Performs role of solution
architect responsible for crafting and defending proposed solutions to
new standalone Safety business opportunities. Formulates operational
budgetary assumptions and takes decisions to steer the creation of the
budget, fulfil required customization of text and data.

Acts autonomously as the Safety Subject Matter Expert (SME) and single
point of contact for Governance, Executives and Integrated Partners in
construction of proposed solution and defends the strategy and pricing
from initiation through to delivery.

Represents as Safety SME. Provide leadership and accountability for
customer-facing collateral and operational support to deliver key
customer messages, working cross-functionally and across the
opportunity lifecycle, integrating lifecycle safety core message
delivery into customer facing material, presentations and meetings.
Collaborate with senior leadership to implement strategic initiatives
and ensure global consistency.

Provide leadership and structure for customer service interface from
scoping stage, through proposal generation, bid defence to transition
of work and service delivery; throughout the development and
commercial lifecycle of the product.

Manage finances for assigned projects. Responsible for updating
financial systems. Work closely with manager on revenue recognition,
invoicing, project budget review, project financial analysis, pursuit
of change orders, etc.

Develop specialist expertise and may act as a Subject Matter Expert
(SME) on departmental or global initiatives.

Support start-up of new projects using standard operating procedures
and best practices, including identifying potential risks during
project initiation and implementing mitigation measures to ensure
seamless delivery at maintenance stage.

Attend meetings with internal (IQVIA cross functional project team
members) and external (Customers and/or oversight group members)
stakeholders. Provides project status updates, defines processes,
project planning/strategy.

Work with Sales and Proposals to ensure rapid, seamless, tailored
responses to opportunities. Drive business growth by improving
customer loyalty through enhanced customer relations, service delivery
excellence and excellent customer communication.

Participate in sales activities, and sales presentations
(capabilities, bid defenses) and proposal development (strategy, costs
and text), as required.

Contributes during client and internal audits and inspections for
assigned projects. Liaise with Quality Assurance staff and management
in the compilation of Corrective Action Plans.

Work closely with Lifecycle Safety management to address problem areas
and customer needs.

MINIMUM REQUIRED EDUCATION AND EXPERIENCETo perform this job
successfully, an individual must be able to perform each essential
duty satisfactorily. The requirements listed below are representative
of the knowledge, skill, and/or ability required. Reasonable
accommodations may be made to enable individuals with disabilities to
perform the essential functions.

Experience Typically requires 2 - 3 years of prior relevant
experience.

Knowledge Requires intermediate level knowledge of principles,
theories, and concepts of a job area, typically obtained through
advanced education combined with experience.

Education

Bachelor&#**Apply on the website**;s Degree (Health science or other
directly related field) Additional Work Experience**Apply on the
website** years&#**Apply on the website**; experience of Lifecycle
Safety (Pharmacovigilance, CEVA, Medical Information, safety
Publishing, Risk Management etc) with project management experience

Equivalent combination of education, training or experience

SKILLS AND ABILITIES

Knowledge of applicable global, regional and local clinical research
regulatory requirement; i.e. Good Clinical Practice (GCP) and
International Conference on Harmonization (ICH) guidelines, IQVIA
Standard Operating Procedures.

_WILLINGNESS TO_ increase knowledge across Lifecycle Safety service
lines and develop new skills. Strong prioritization (critical
timelines), planning and organizational skills. Effective verbal and
written communication skills including ability to work and lead
teleconferences. Effective collaborative, organizational and
delegation skills. Independently work on multiple projects and manage
competing priorities.

_ABILITY TO_ manage ambiguity. Strong presentation (independently
present at internal/external meetings) skills; report writing skills
and customer focus skills. Accountability, ownership and transparency.
Demonstrates independent judgment, negotiating, decision-making, and
problem-solving skills. Possesses knowledge of business acumen and
financial analytical skills, tactical planning, and budgeting.
Creative and innovative, initiative and pro-active. Effective
motivating, influencing and conflict resolution skills.

_ABILITY TO_ establish and maintain effective working relationships
with coworkers, managers and customers. Standard ADA Settings

The physical demands described here are representative of those that
must be met by an employee to successfully perform the essential
functions of this job. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential functions

Sit at a desk or table with some walking, standing, bending, stooping,
or carrying of light objects. Use hands and fingers to handle and
manipulate objects and/or operate equipment.

Travel

_REQUIREMENTS_

Requires frequent domestic and occasional international travel

Join UsMaking a positive impact on human health takes insight,
curiosity, and intellectual courage. It takes brave minds, pushing the
boundaries to transform healthcare. Regardless of your role, you will
have the opportunity to play an important part in helping our clients
drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop
learning.
**Apply on the website**-**Apply on the website**:**Apply on the
website**:**Apply on the website** IQVIA? is the leading human data science company focused on helping
healthcare clients find unparalleled insights and better solutions for
patients. Formed through the merger of IMS Health and Quintiles, IQVIA
offers a broad range of solutions that harness the power of healthcare
data, domain expertise, transformative technology, and advanced
analytics to drive healthcare forward.

The RoleManages the delivery of lifecycle safety scope from pre-award,
project initiation / transition to closeout.

Ensures quality deliverables are presented on time and within budget;
coordinates work streams and efforts of cross-functional project teams
while monitoring the use of consistent tools and methodologies;
identifies and evaluates potential project risks and develops
mitigation plans; and serves as the primary point of contact with the
project customer.

Job Overview

Responsible for management and service delivery excellence for
assigned projects, covering single or multiple Lifecycle Safety
functions (clinical trial and / or post-market). Provide leadership
and accountability for customer-facing activities and oversight of
operational service delivery, working cross-functionally and across
the opportunity lifecycle, integrating delivery into one seamless and
transparent program for customers, aligned by accounts. Collaborate
with global management team and integrated partners to develop and
implement strategic initiatives/solutions to expand business,
partnership, strengthen overall relationship and ensure global
consistency.

Responsibilities

Manage customer interface and communication for assigned projects.
Represent Lifecycle Safety on projects and serve as primary point of
contact within Lifecycle Safety for all internal and external
customers; liaise between internal/external customers and Lifecycle
Safety Operational teams.

Manage customer deliverables for assigned projects and bring
continuity to project design and delivery through customer delivery.
Tactical, day-to-day customer-facing leadership at project level.

_RESPONSIBILITIES_ include project planning (timelines, deliverables),
defining project/scope management, quality management and project
financial management.

May act as an account owner over a program or customer portfolio and
therefore report program/portfolio level metrics and provide oversight
of projects they do not directly lead. Performs role of solution
architect responsible for crafting and defending proposed solutions to
new standalone Safety business opportunities. Formulates operational
budgetary assumptions and takes decisions to steer the creation of the
budget, fulfil required customization of text and data.

Acts autonomously as the Safety Subject Matter Expert (SME) and single
point of contact for Governance, Executives and Integrated Partners in
construction of proposed solution and defends the strategy and pricing
from initiation through to delivery.

Represents as Safety SME. Provide leadership and accountability for
customer-facing collateral and operational support to deliver key
customer messages, working cross-functionally and across the
opportunity lifecycle, integrating lifecycle safety core message
delivery into customer facing material, presentations and meetings.
Collaborate with senior leadership to implement strategic initiatives
and ensure global consistency.

Provide leadership and structure for customer service interface from
scoping stage, through proposal generation, bid defence to transition
of work and service delivery; throughout the development and
commercial lifecycle of the product.

Manage finances for assigned projects. Responsible for updating
financial systems. Work closely with manager on revenue recognition,
invoicing, project budget review, project financial analysis, pursuit
of change orders, etc.

Develop specialist expertise and may act as a Subject Matter Expert
(SME) on departmental or global initiatives.

Support start-up of new projects using standard operating procedures
and best practices, including identifying potential risks during
project initiation and implementing mitigation measures to ensure
seamless delivery at maintenance stage.

Attend meetings with internal (IQVIA cross functional project team
members) and external (Customers and/or oversight group members)
stakeholders. Provides project status updates, defines processes,
project planning/strategy.

Work with Sales and Proposals to ensure rapid, seamless, tailored
responses to opportunities. Drive business growth by improving
customer loyalty through enhanced customer relations, service delivery
excellence and excellent customer communication.

Participate in sales activities, and sales presentations
(capabilities, bid defenses) and proposal development (strategy, costs
and text), as required.

Contributes during client and internal audits and inspections for
assigned projects. Liaise with Quality Assurance staff and management
in the compilation of Corrective Action Plans.

Work closely with Lifecycle Safety management to address problem areas
and customer needs.

MINIMUM REQUIRED EDUCATION AND EXPERIENCETo perform this job
successfully, an individual must be able to perform each essential
duty satisfactorily. The requirements listed below are representative
of the knowledge, skill, and/or ability required. Reasonable
accommodations may be made to enable individuals with disabilities to
perform the essential functions.

Experience Typically requires 2 - 3 years of prior relevant
experience.

Knowledge Requires intermediate level knowledge of principles,
theories, and concepts of a job area, typically obtained through
advanced education combined with experience.

Education

Bachelor&#**Apply on the website**;s Degree (Health science or other
directly related field) Additional Work Experience**Apply on the
website** years&#**Apply on the website**; experience of Lifecycle
Safety (Pharmacovigilance, CEVA, Medical Information, safety
Publishing, Risk Management etc) with project management experience

Equivalent combination of education, training or experience

SKILLS AND ABILITIES

Knowledge of applicable global, regional and local clinical research
regulatory requirement; i.e. Good Clinical Practice (GCP) and
International Conference on Harmonization (ICH) guidelines, IQVIA
Standard Operating Procedures.

_WILLINGNESS TO_ increase knowledge across Lifecycle Safety service
lines and develop new skills. Strong prioritization (critical
timelines), planning and organizational skills. Effective verbal and
written communication skills including ability to work and lead
teleconferences. Effective collaborative, organizational and
delegation skills. Independently work on multiple projects and manage
competing priorities.

_ABILITY TO_ manage ambiguity. Strong presentation (independently
present at internal/external meetings) skills; report writing skills
and customer focus skills. Accountability, ownership and transparency.
Demonstrates independent judgment, negotiating, decision-making, and
problem-solving skills. Possesses knowledge of business acumen and
financial analytical skills, tactical planning, and budgeting.
Creative and innovative, initiative and pro-active. Effective
motivating, influencing and conflict resolution skills.

_ABILITY TO_ establish and maintain effective working relationships
with coworkers, managers and customers. Standard ADA Settings

The physical demands described here are representative of those that
must be met by an employee to successfully perform the essential
functions of this job. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential functions

Sit at a desk or table with some walking, standing, bending, stooping,
or carrying of light objects. Use hands and fingers to handle and
manipulate objects and/or operate equipment.

Travel

_REQUIREMENTS_

Requires frequent domestic and occasional international travel

Join UsMaking a positive impact on human health takes insight,
curiosity, and intellectual courage. It takes brave minds, pushing the
boundaries to transform healthcare. Regardless of your role, you will
have the opportunity to play an important part in helping our clients
drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop
learning.
**Apply on the website**-**Apply on the website**:**Apply on the
website**:**Apply on the website**

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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