Talent.com
CSL
Vaccines Safety Sciences LeadCSL • EMEA, GB, Berkshire, Maidenhead, CSL Behring
Vaccines Safety Sciences Lead

Vaccines Safety Sciences Lead

CSL • EMEA, GB, Berkshire, Maidenhead, CSL Behring
14 days ago
Job type
  • Full-time
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 and CSL Plasma at .

Our Benefits

Create a job alert for this search

Vaccines Safety Sciences Lead • EMEA, GB, Berkshire, Maidenhead, CSL Behring

Similar jobs

Global Formulation Safety Lead - Risk & Strategy

Meeveem LimitedMaidenhead, England, GB
Full-time

Meeveem Limited is seeking a Director, Global Safety Lead in Maidenhead, UK.This pivotal role focuses on ensuring the safety of medicinal products throughout their lifecycle and involves rigorous a... Show more

 • Promoted

Strategic Sourcing Lead – Life Sciences (EMEA)

Kyowa Kirin InternationalMarlow, England, GB
Full-time

Kyowa Kirin International is seeking a Procurement Manager in Marlow, UK to lead end-to-end sourcing across non-supply chain spend in EMEA, acting as primary contact for stakeholders and suppliers.... Show more

 • Promoted

Regional Health & Safety Leader, Multi-Site Logistics

JD.COM INTERNATIONAL UK LTDMilton Keynes, England, GB
Full-time

COM INTERNATIONAL UK LTD is seeking a Regional Health and Safety Manager based in Milton Keynes.This role involves leading and maintaining health and safety compliance across distribution centres a... Show more

 • Promoted

Casualty Pricing Lead

High Finance (UK) LimitedSlough, ENG, GB
Full-time

We're partnering with a leading global specialty insurer to recruit a Lead Pricing Actuary.This role is not limited to but includes:.Leading pricing across a diverse Specialty portfolio includi... Show more

 • Promoted

HS&E Advisor

Orion Electrotech SalesMarlow, ENG, GB
Full-time

My client has over 75 years of experience driving advancement in the aviation and defence industries.As the HSE Advisor, youll be responsible for the implementation of HS&E Management policies ... Show more

 • Promoted

Principal Engineer Product Safety

BAE SystemsGuildford, ENG, GB
Full-time

Principal Engineer Product Safety.Barrow-in-Furness, Filton or Broad Oak Hybrid.We offer a range of hybrid and flexible working arrangements please speak to your recruiter about the options for thi... Show more

 • Promoted

Biosecurity specialist - information

Royal Horticultural SocietyWoking, England, GB
Full-time

Love plants? Great at explaining things? Excited by teaching, training, engagement and the possibility of helping people protect plant health? Join the RHS Biosecurity Team as our.Biosecurity Speci... Show more

 • Promoted

Fractional Health and Safety Advisor / Manager

GofractionalAmersham, England, GB
Full-time

Flitetec is looking for a practical and experienced Health and Safety Advisor / Manager to support our aviation component distribution and aircraft interior manufacturing business.This opportunity ... Show more

 • Promoted

Health and Safety Coordinator

Pioneer SelectionAylesbury, GB
Part-time +1

Up to £38,000 (Depending on Experience & Hours Worked).Part-Time – 25–30 Hours per Week (School Hours Available).Month Fixed Term Contract (Maternity Cover).Job Role of the Health & Safety Coordina... Show more

 • Promoted

Regional SHE Leader: Safety, Health & Compliance

Element Materials TechnologyHigh Wycombe, England, GB
Full-time

Element Materials Technology is seeking an Area Safety Health and Environmental (SHE) Manager in High Wycombe to ensure divisional workstreams operate efficiently through effective SHE programs.Thi... Show more

 • Promoted

H&S Coordinator

OrionAylesbury, ENG, GB
Part-time +1

Health & Safety Coordinator12-Month Fixed-Term Contract (Maternity Cover)Part-Time 2530 Hours per Week (School Hours Considered)Salary: £26,000 £38,000 (Pro Rata, Dependent on Exper... Show more

 • Promoted

Regional Safety, Health & Environment Lead

Element Materials Technology Ltd.High Wycombe, England, GB
Full-time

Element Materials Technology Ltd.Area Safety Health and Environmental SHE Manager in High Wycombe.This role is critical for ensuring efficient operational workstreams through the effective planning... Show more

 • Promoted

Lead Safety Engineer

NRLWoking, England, GB
Full-time

Seeking expressions of interest for a potential upcoming project with starts expected towards the end of June.We are looking for an experienced Lead Safety Engineer to provide technical leadership ... Show more

 • Promoted

Pharma Quality Assurance Lead – QMS & Compliance

Alliance HealthcareWoking, England, GB
Full-time

Alliance Healthcare in Woking seeks a Quality Assurance professional to manage quality processes and documentation in support of our pharmaceutical deliveries.This full-time position requires subst... Show more

 • Promoted

Health and Safety Coordinator

AlplaAston Clinton, ENG, GB
Temporary

Health & Safety Coordinator.Part-Time | 2530 Hours per Week (School Hours Available).Dependant on experience and hours.We are looking for a proactive and organised Health & Safety Coordinat... Show more

 • Promoted

Lead Scientist - R&D Purification

LonzaSlough, England, GB
Full-time

Join Lonza’s cutting‑edge R&D team in Slough and play a pivotal role in advancing next‑generation purification technologies.This is a hands‑on scientific role where you will drive innovation in dow... Show more

 • Promoted

Health & Safety Leader — Telecom & Construction

XAD TechnologiesSlough, England, GB
Full-time

A leading telecommunications and construction company in Slough is seeking a Health Safety Manager to develop and implement safety policies.The ideal candidate will have a bachelor's degree in a re... Show more

 • Promoted

Senior QA Validation & Projects Lead

Alliance MedicalGuildford, England, GB
Full-time

Alliance Medical in Guildford is seeking a QA Validation & Projects Manager to provide leadership in validation and quality across UK operations.This senior role involves ensuring regulatory compli... Show more

 • Promoted

Global Head of Drug Safety & Pharmacovigilance

Amicus Therapeutics, Inc.Marlow, England, GB
Full-time

A global biotechnology company in Marlow is seeking a Vice President of Global Drug Safety to lead their pharmacovigilance strategy for post-approval products.You will ensure compliance with regula... Show more

 • Promoted

Global Pharmacovigilance Quality & Regulatory Lead

CSLMaidenhead, England, GB
Full-time

A global biopharmaceutical leader is seeking a Head of Pharmacovigilance and Regulatory Quality Assurance.This pivotal role involves leading compliance and quality functions while overseeing strate... Show more