Safety Services Project Leader
Posted on: January 15, 2022
Great home-based opportunity to join Parexel's best in class
Global Medical Sciences Team as a Safety Services Project Leader
(SSPL)/(Drug Safety Project Manager)! This highly visible role
combines your drug safety, post-marketing, and product launch
experience with your project management expertise.
When serving as the Functional Leader, the SSPL will provide
leadership, management, general oversight and direction for Medical
Safety Services projects, including but not limited to medical
monitoring, clinical and post -marketing pharmacovigilance. The
SSPL will also be responsible to ensure client satisfaction,
project team management and communication, quality, adequate
resource planning and allocation, and financial performance. The
SSPL will serve as the primary point of contact and communication
between the Parexel Project Leader, the Sponsor team and Medical
Services worldwide and, with the Global Lead Physician (GLP) be
accountable for performance of the entire Medical Services team on
As a Functional Leader, the SSPL will be responsible for
management, general oversight and direction for Safety Services
projects, including medical monitoring and clinical and post -
marketing Pharmacovigilance (PV) projects. The SSPL will also be
responsible to provide input, advice and direction for project
resource planning and allocation, and overall Safety Services
project team management. The SSPL will also be a point of
communication contact and liaison with internal and external
stakeholders, strategic planning teams and project review teams
including Quality, financial performance and customer feedback. The
SSPL will be responsible for consistent and complete communication
between all members of the Worldwide Safety team.
In addition, in the functional lead role, the SSPL will be
responsible to provide input, advice and direction for resource
planning and allocation working closely with the global resource
planning office, project team management, stakeholder liaison,
strategic planning and reviews:
- Management, support, direction, coordination and planning for
any medical and other pharmacovigilance (PV) related activities,
including oversight of and contribution to PV consulting
- Strategic input, including providing subject matter expertise
for Safety Services in the planning and setup of projects,
including costing, budgeting, resourcing, workflow and process
design and analysis.
- Provide training and mentoring to other, less experienced SSPLs
and Safety Operations Staff.
- Timely contribution to and strategic input and review of
proposals (RFP), and contracts as required.
- Liaison with internal (e.g. business operations, account
management, Parexel Consulting) and external stakeholders (e.g.
clients, third party vendors, health authorities).
- Represent Medical/Safety Services if and when required for
internal and external matters.
- Provide support in internal and external audits and inspections
and ensure that corrective actions are implemented as
- Contribute to Medical and PV Operations resource planning and
- Contribute to the costing of Medical and PV Operations
projects, including the review of and improvement of performance
metrics and costing tools. Qualifications -Attend and lead client
meetings, and bid-defense meetings.
- Provide timely input and feedback to process improvement.When
serving as the Project Leader on standalone projects, the SSPL is
independently responsible for all Project Leader tasks and
deliverables according to SOPs on assigned projects including:
- Attend and lead Bid Defense Meetings along with the BD
- Develop and maintain a formal project plan with all key
milestones, budgets, and resources assigned to specific tasks and
outcomes. Define metrics for reporting against plan.
- Ensure that all standard project systems and tools are set up
correctly and functioning appropriately.
- Implement operational strategy as defined in the project plan
and makes changes to the plan to ensure desired results.
- Proactively solve problems in collaboration with the client and
- Close out of all project activities upon project completion;
perform financial reconciliation and system closeout.In this
capacity the SSPL will be responsible for the financial management
/administration of the function-led projects according to Corporate
Business Operating Procedures to include:
- Maintenance of a project plan
- Monthly revenue recognition and forecast activities
- Invoicing according to contract -service and pass through
- Monthly control/adjustment of time reported
- Project close out activities WW (in cooperation with Project
- Provide project information to Project Analysts
- First point of contact for the client for all financial related
- Coordination/management of project teamIn activities involving
project management, the SSPL will be acting as the Medical
functional lead working with the overall Parexel PL or as the PL if
a the project is a function-led Medical project, to ensure that
projects run on time, on budget, and in accordance with client
contract, SOPs, quality standards and regulatory guidelines.
Projects may involve the following tasks:
- Clinical trial safety management
- Clinical trial medical monitoring
- Clinical trial cumulative and/or per-patient data review
- Post-marketing PV
- Any other activities as required by lifecycle drug safety
services.The SSPL will be required to maintain PV knowledge and
knowledge of any other Medical service processes as required by
regulations and SOPs, and document competencies n the training
The SSPL will be the single operational point of contact in
Medical/Safety Services for this communication.
To ensure success, qualified candidates should have the following
- Excellent knowledge of drug safety, drug development, and
ability to interpret/apply global safety regulations
- Previous post-marketing and/or product launch experience
- Experience in evaluation of safety data and the preparation of
- Experience w/ computer applications including database
management and pharmacovigilance related systems
- Ability to:build effective project teams, motivate, delegate,
and drive timely/quality decision-making
gain trust and confidence with a variety of clients and w/in
create a sense of urgency and take a solutions-based approach
prioritize and manage multiple, varied tasks w/ enthusiasm and
attention to detail
thrive in a matrix environment and to value the importance of
work independently w/ oversight guidance
- Customer focus, commitment to quality management and problem
- Effective communication and negotiation skills
- Budget management skills
- Basic understanding of all aspects of project life-cycle
- Proven track record of developing client relationships
- Degree in Pharmacy, Nursing, Life Science, or other
health-related field, or equivalent qualificationEmployment is
contingent on disclosure of your COVID-19 vaccination status and,
if relevant, proof of vaccination.
EEO Disclaimer Parexel is an equal opportunity employer. Qualified
applicants will receive consideration for employment without regard
to legally protected status, which in the US includes race, color,
religion, sex, sexual orientation, gender identity, national
origin, disability or protected veteran status.
Keywords: PAREXEL, Wilmington , Safety Services Project Leader, Other , Wilmington, North Carolina
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