Senior Pharmacovigilance Scientist (f/m/d) - Post-marketing products

CSL; Glattbrugg; Híbrido; CHF 120.000 - 170.000; Jornada completa

Descripción de la vacante

CSL Behring is seeking an experienced Pharmacovigilance Scientist in Switzerland to lead safety review activities across the product lifecycle and work closely with the Global Safety Lead. You will conduct signal detection, review literature for safety insights, and contribute to ASRs and regulatory reports while mentoring junior PV colleagues.

The role requires at least 3 years in PV, strong knowledge of GCP/ICH, and excellent English communication.

Formación

• Bachelor’s degree or equivalent in pharmaceutical/biological sciences; Medicine/Pharmacy preferred
• At least 3 years’ experience as a Pharmacovigilance scientist or equivalent
• Understanding of pharmacovigilance regulations and safety methodology
• Strong analytical problem-solving and cross-functional collaboration skills
• Proficient in English with excellent written and verbal communication
• Ability to work independently and in a team in a cross-functional environment

Responsabilidades

• Lead the safety review process and evaluation of safety data throughout the product lifecycle with the Global Safety Lead
• Perform end-to-end signal detection and analysis on safety datasets from multiple sources and present summaries
• Review publications for important safety information for use in ASRs
• Provide input to ASRs (PSURs, DSURs, PADERs, RMPs) and regulatory documents
• Organize insights for internal Safety Management Teams
• Support product development teams with PV expertise related to clinical data
• Develop response strategies and analyses for safety questions or regulatory requests
• Mentor junior PV scientists and assist with onboarding
• Other activities including case adjudication, review of IBs/CSRs, SOP updates, SME support

Conocimientos

Pharmacovigilance

Signal detection

Safety data analysis

Regulatory compliance

ICH GCP

English communication

Educación

Bachelor’s degree in pharmaceutical/biological sciences

Medicine and Pharmacy preferred

Herramientas

Microsoft Excel

Descripción del empleo

Responsibilities:

• Lead the safety review process and evaluation of safety data throughout the product lifecycle using a combination of quantitative and qualitative approaches, in partnership with the Global Safety Lead (GSL)
• Perform end to end signal detection and analysis activities on safety data sets from various sources, and present summaries of the data in a meaningful way
• Review publications from the scientific and medical literature for important safety information for further use in various analyses or aggregate safety reports (ASRs)
• Provide strategic input and/or contributions to various ASRs (Periodic Safety Update Reports, Development Safety Update Reports, PADERs, Risk Management Plans etc.)
• Organize and provide key insight to internal cross functional Safety Management Teams (SMTs)
• Support product development teams (such as the Study Execution Team and the Clinical Development Teams) with PV related expertise relating to clinical data
• Develop response strategy and perform required analyses for any safety related questions from internal sources and/or external regulatory requests
• Mentor more junior members of the PVS community, including assisting with on-boarding and providing advice on day-to-day tasks
• Other Activities as required, including but not limited to: case adjudication, review of key clinical documents (IBs, CSRs, etc), support in SOP updates, subject matter expert support for dedicated PVS activities, etc.

Qualifications:

• Bachelor’s or equivalent degree (depending on national educational system) required in the pharmaceutical, nursing or biological, or sciences (Degree in Medicine and Pharmacy is preferred)
• At least 3 years’ experience as a Pharmacovigilance scientist or equivalent position in a closely related discipline
• Understanding of pharmacovigilance and global clinical safety methodology and regulations, guidelines, and standards.
• Ability to provide solutions for issues/challenges that may arise during the course of a project
• Knowledge and experience of safety monitoring and signal detection preferred.
• Understanding of ICH GCP and drug development preferred
• Computer proficiency in basic database entry and graphics presentations (e.g.,Microsoft Excel or equivalent).
• 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
• Ability to work independently and as a team player, working in a cross functional environment
• 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/.

Benefits

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

Inclusion and Belonging

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

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