In-Demand Vaccines safety sciences Jobs

Vaccines Safety Sciences Lead
CSL Behring —Melbourne VIC
- Full-time
- Master's degree
- Administrative experience
- Bachelor's degree
6d
Med Lab Tech Gr 1
St Vincent's Health Australia —Melbourne VIC
- $59,207 - $76,346 a year
- Full-time
- Laboratory experience
- Maintenance
- No degree
6d
Science Graduate
Icon Group —Greater Adelaide SA
- Overtime
Haemostasis Scientific Manager
SA Health —Adelaide SA
- $111,870 - $125,306 a year
- Full-time
- Laboratory experience
- Bachelor's degree
- Leadership
- Annual leave
- Employee assistance program
4d
Senior Clinical Research Associate - FSP
Parexel —Remote
- Weekend availability
- Nursing
- Patient monitoring
- English
Scientist
Healius Corp. —Alice Springs NT
- 8 hour shift
- Bachelor's degree
- No degree
- Organisational skills
- Health insurance
- Employee assistance program
7d
Research Sleep Scientist
Eastern Health —Box Hill VIC
- Part-time
- Laboratory
- Microsoft Excel
- Patient monitoring
- Health insurance
- Employee assistance program
7d
Medical Scientist
Eastern Health —Ringwood East VIC
- Part-time
- Microsoft Excel
- Laboratory experience
- Analysis skills
- Health insurance
- Employee assistance program
Sleep Scientist
Royal Children's Hospital —Melbourne Western Suburbs VIC
- $63,674.00 - $91,785.20 a year
- Hybrid work
- Medicine
- Bachelor's degree
- Paediatrics
- Employee assistance program
4d
Scientist Grade 1
St Vincent's Health Australia —Melbourne VIC
- $63,674.00 - $91,785.20 a year
- Weekend availability
- Bachelor's degree
- Communication skills
- Time management
- Employee assistance program
- Employee discount
12d
Immunology Scientist
Healius Corp. —Murarrie QLD
- Full-time
- Laboratory experience
- Bachelor's degree
- Organisational skills
- Health insurance
- Employee assistance program
3h
Sleep Scientist - Grade 2
The Royal Children's Hospital —Parkville VIC
- $94,478.80 - $106,906.80 a year
- Part-time
- Hybrid work
- Medicine
- Bachelor's degree
- Paediatrics
- Employee assistance program
4d
Sleep Scientist - Casual
The Royal Children's Hospital —Parkville VIC
- $63,674.00 - $91,785.20 a year
- Full-time
- Hybrid work
- Medicine
- Bachelor's degree
- Paediatrics
- Employee assistance program
4d
Clinical Research Coordinator
GenesisCare —St Leonards NSW
- Full-time
- Nursing
- Vital signs
- Microsoft Office
(Fixed Term) Manufacturing Associate
Moderna, Inc. —Melbourne VIC
- Overtime
- Bachelor's degree
- No degree
- In-person
- Annual leave
Technical Officer Pool - Casual
SA Health —South Australia
- $24.94 - $35.80 an hour
- On call
- Laboratory
- Laboratory experience
- Organisational skills
Senior Technical Officer (TGO2) Pool
SA Health —South Australia
- $75,240 - $79,880 a year
- Full-time
- Laboratory experience
- Organisational skills
- Leadership
Medical Imaging Technologist
St Vincent's Health Australia —Melbourne VIC
- $70,590 - $103,724 a year
- Full-time
- Bachelor's degree
11d
Head of Global Labelling
CSL Seqirus —Melbourne VIC
- Full-time
- Leadership
Scientific Officer - Multi Skilled
Healius Corp. —Sydney NSW
- Full-time
- Bachelor's degree
- No degree
- Organisational skills
- Health insurance
- Employee assistance program
3h

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Vaccines Safety Sciences Lead

CSL Behring -
Melbourne VIC

Apply Now

Job Details

Full-time
6 days ago

Qualifications

Master's degree
Administrative experience
Bachelor's degree
Leadership

Full Job Description

Entity: CSL Behring

Job Category: Research Development & Sciences

Job Family: Pharmacovigilance Operations

Job Type: Full Time

Location: Melbourne, Victoria, Australia

Employer Reference: R-284072

Job Description

Responsibilities:• Manages and directs functions to comply with standard operating procedures, regulatory safety and pharmacovigilance and business technology quality standards in compliance with national and international regulations, such as relevant GxP guidelines and national and international legislations and regulations as well as aggregate safety reports in area of responsibility.• Oversees evolving pharmacovigilance legislations and provides strategic direction for implementation of required changes to the global PV system; this may involve cross-functional approaches, including multiple interface functions.• Establishes and ensures maintenance of regulatory required documents such as the PSMF, in line with international regulations, guidelines and internal standards.• Supports the preparation and conduct of PV inspections and audits, as required and organizes or supports the back-office for regulatory PV inspections.• Oversees/leads signal detection and management processes.• Implements pharmacovigilance processes and ensures the uniform and timely analysis of safety data.• Leads or contributes important initiatives to write new processes, or improve/optimize current processes in the functional area; acts as an expert on cross-functional teams for process optimization where the input of safety sciences is required.• Provides day-to-day management support and direction to direct reports within the functional area.• Contributes to study activities or post-marketing activities involving safety data and analysis.• Develops and provides advanced analytical outputs to global teams to support analyses and decision making based on safety data.• Development of new or enhancement of existing standard reports per company BT quality standards.• Gathers, details, and documents user requirements in a way that is useful and meaningful to their business area experts and the technical team implementing the solution.• Analyzes impact from changes to the database or changes in user/reporting requirements. • Directs transfer of business requirements into technical solutions.• Explores, analyzes and introduces data visualization tools to make complex analyses accessible to a broad audience.• Business Process and/or Inspection SME/Leads for areas of responsibility. • May provide medical evaluation of adverse event reports. • Assists in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications, product labeling/package inserts and other reports as necessary.Qualifications:• Bachelor degree, Medical Documentation, or equivalent in a life science discipline or 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.• 8-10 years' Pharmacovigilance experience in multinational pharmaceutical industry. • 6+ years' experience in a leadership role.• Expert knowledge of national/international pharmacovigilance regulations and PV processes.• Knowledge of local/international relevant GxP regulations, IT standards and other relevant legislations such as legislations related to privacy protection.• Experience with regulatory inspections. • Experience in administration of complex data sets. • Experience in project-managing CAPA and SOP development.• Experience with GxP.• Experience with relevant software applications.Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

Apply Now

Refine Your Search

vaccines safety sciences jobs

Vaccines Safety Sciences Lead

Med Lab Tech Gr 1

Science Graduate

Haemostasis Scientific Manager

Senior Clinical Research Associate - FSP

Scientist

Research Sleep Scientist

Medical Scientist

Sleep Scientist

Scientist Grade 1

Immunology Scientist

Sleep Scientist - Grade 2

Sleep Scientist - Casual

Clinical Research Coordinator

(Fixed Term) Manufacturing Associate

Technical Officer Pool - Casual

Senior Technical Officer (TGO2) Pool

Medical Imaging Technologist

Head of Global Labelling

Scientific Officer - Multi Skilled

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