Principal Clinical Safety Scientist

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Posted
Jan 28, 2021
Ref
R-129317
Hotbed
Pharm Country
Required Education
Masters Degree/MBA
Position Type
Full time
About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Position Purpose:
The Principal Clinical Safety Scientist (Associate Director) is the site manager of the Clinical Safety Scientists
and Senior Clinical Safety Scientists, who are integral members of the Global Clinical Safety and
Pharmacovigilance Safety Sciences function as key contributors to the lifecycle risk management activities of
CSL products.
He/She ensures implementation of GVP compliant PV standards, processes and safety risk management
activities by the Clinical Safety Scientists under their management.
They also provide expert input into strategic development and improvement of GCSP processes that involve
clinical safety scientists, with the goal of proactive safety management throughout the lifecycle.
Cross functional collaboration with all GCSP Departments and other interfaces with risk management, signal
detection safety management team and reporting & analytics processes is key.

Reporting Relationships:
Roles that this position reports to:
Director, Safety Sciences and Signal Management

Roles that report to this position:
o Senior Clinical Safety Scientists
o Clinical Safety Scientists

Main Responsibilities and Accountabilities: List the roles and responsibilities of the position
1. Supervision and oversight of activities of Clinical Safety Scientists under their responsibility during
preparation and conduct of studies in clinical development as well as in postmarketing phase (i.e.
phase 4 studies or observational studies); activities of Clinical Safety Scientists include:
  • Lead the active monitoring of the safety profile via routine aggregate signal detection and literature surveillance processes
  • Drive the ongoing activities of the Safety Management Team, including the cross-functional contribution to the knowledge of the safety profile of the assigned products
  • Provide strategic oversight for the overall preparation of risk management plans in collaboration with the Clinical Safety Physician, outlining the approach to the management of safety concerns throughout the product life cycle and input/agreement with interface functions via the Safety Management Team.
  • Lead the preparation of sections of risk management plans and aggregate reports assigned to the Clinical Safety Scientist/Clinical Safety Physician, and assist the Clinical Safety Physician with the governance approval of the contents of these plans.
  • Contribute to study start-up activities for development products, such as review of study protocol, investigators brochure, leading the production of the periodic reporting plan and other safety relevant documentation
  • Contribute to authoring safety related justification documents in support of company/development core safety information (CCSI/DCSI) and safety relevant product label updates
  • Conducting analyses for aggregate safety monitoring during study conduct
  • Provide strategic input or oversight and contribute individual safety relevant key sections for the preparation of aggregate safety reports (Periodic Safety Update Reports,
  • Development Safety Update Reports, PADERs etc.) according to agreed processes and timelines. In collaboration with aggregate reporting/safety medical writing, ensuring cross-functional discussion and contribution to the report strategy and preparation.
  • Ensuring that the contents of the report reflect the ongoing safety activities for the product.
  • Contribution to quality improvement: Review, prepare, and/or update local and global SOPs and working instructions as required.
  • Collaborating closely during their daily work with the Clinical Safety Physicians, to ensure a solid partnership that is able to meet the needs of the business as well as ensure regulatory compliance for the overall safety management of the products they are assigned

2. Manage the assignment of Clinical Safety Scientists to projects, and initiation of their collaboration with the respective safety physicians. Assisting the Lead, Safety Sciences and Signal
Management with resource planning and budgeting activities.
3. Support Clinical Safety Scientist development, through mentoring, leadership and training
4. In addition to the managerial tasks the Principal Clinical Safety Scientist is expected to perform
the duties of a Clinical Safety Scientist and take over responsibility of a product.
5. Inspection readiness: ensures inspection readiness for signal detection and risk management
activities for the products under their responsibility. Acts as a subject matter expert (SME) during
inspections as needed. Ensures the preparedness of Clinical Safety Scientists under their direction
6. Process development/ continuous improvement: Leads or contributes important initiatives to
write new processes, or improve/optimize current processes in the areas of signal detection and
risk management. Acts as an expert on cross-functional teams for process optimization where the
input of safety sciences is required.
7. Fosters a leadership culture which attracts, develops, and retains high caliber clinical safety
scientists committed to providing valuable and creative input to CSL projects to achieve or exceed
company goals.

Position Qualifications and Experience Requirements:

Education:

Minimum of Masters (or international equivalent) in science, medicine/health
sciences, or epidemiology, or; Bachelor degree (or international equivalent) in science, medicine/health sciences,
or epidemiology with an increased experience requirement of an additional 3 years industry experience in a related role.

Experience:

-At least 5 years progressive experience within the Pharmaceutical or Biotech
industry with at least 3 years in direct experience as a Clinical Safety Scientist or
closely-related function.
-Experience in signal management specifically signal detection in varying data
sources across the product life cycle, chairing global Safety Management Teams, as
well as problem solving in the methods and approaches to answering complex
regulatory queries.
-Experience in leading and developing high-performing teams.

Competencies:

Strong leadership skills, diplomacy and desire for continuous improvement are of
paramount importance to this position
Advanced understanding of pharmacovigilance and global clinical safety
methodology and regulations, guidelines and standards. and the ability to provide
sound advice to team members on their interpretation
Understanding of ICH GCP and drug development
Advanced knowledge and experience of safety monitoring and signal detection.
Experience with process development and improvement
Excellent written and verbal communication skills in English, with the ability to
evaluate, interpret and synthesize scientific data.
Self-motivated, able to prioritize and plan effectively
The expertise, determination and courage to resolve or escalate issues as
appropriate.
Ability to work independently and as team player, working in a cross functional
environment
Experience as Clinical Safety Scientist
Computer proficiency in basic database entry and graphics presentations (e.g.
Microsoft Excel or equivalent).