Clinical Safety Manager (m/f/d)

Valneva; Wien; Vor Ort; EUR 40 000 - 60 000; Vollzeit

Zusammenfassung

A leading biotech company in Austria is seeking a Clinical Safety Manager to oversee safety management across Phase 1-4 clinical trials. The candidate will ensure regulatory compliance and manage external safety service providers while collaborating with clinical teams. Applicants should have a relevant bachelor's degree and experience in clinical research or pharmacovigilance. The role offers a competitive salary and a dynamic work environment.

Leistungen

Flexitime & Compensation days

Performance-related bonus & Lunch vouchers

Unlimited access to LinkedIn Learning

Free access to sports and fitness activities

Qualifikationen

• At least 3 years of experience in clinical research, preferably focused on clinical safety.
• Experience with vendor oversight and safety data review is a plus.
• Familiarity with global safety regulations (ICH-GCP, FDA, EMA) is beneficial.

Aufgaben

• Oversee safety management across Phase 1-4 clinical trials.
• Ensure regulatory compliance and manage external safety service providers.
• Support the Clinical Safety Physician in medical review of safety cases.

Kenntnisse

Attention to detail

Communication skills

Organizational skills

Leadership

Ausbildung

Bachelor's degree in Life Sciences or a related field

Tools

Safety databases (e.g., Argus)

Jobbeschreibung

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We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.

Responsibilities

We are seeking a Clinical Safety Manager responsible for overseeing safety management across Phase 1-4 clinical trials. This role ensures regulatory compliance (ICH, FDA/EMA), manages external safety service providers, and supports ongoing safety surveillance. Working closely with the Clinical Safety Physician and cross-functional teams, the manager plays a key role in maintaining safety standards across clinical development programs.

• Manage clinical safety activities across Phase 1-4 trials, ensuring compliance with global regulatory requirements and internal SOPs.
• Collaborate with cross-functional teams and external partners (e.g., CROs, vendors) to ensure effective safety oversight and communication.
• Support the Clinical Safety Physician in the medical review of safety cases, including serious adverse events (SAEs), adverse events of special interest (AESIs), and pregnancy reports.
• Monitor and assess vendor performance in safety case processing, reporting, and compliance with contractual obligations.
• Prepare and distribute regular safety compliance and performance reports; coordinate issue resolution and necessary follow-up.
• Contribute to signal detection activities, periodic safety data reviews, and the development of aggregate safety reports.
• Review clinical trial and regulatory documents from a safety perspective, and support the development of key safety documents and plans (e.g., Safety Management Plans, SDEAs).
• Organize and participate in safety-related meetings, including DSMB and SRC meetings, and support risk-benefit assessments.
• Participate in audits and inspections, contribute to SOP development, and deliver training on safety procedures.
• Maintain accurate documentation and filing of safety-related records in compliance with regulatory and company standards

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.

Responsibilities

We are seeking a Clinical Safety Manager responsible for overseeing safety management across Phase 1-4 clinical trials. This role ensures regulatory compliance (ICH, FDA/EMA), manages external safety service providers, and supports ongoing safety surveillance. Working closely with the Clinical Safety Physician and cross-functional teams, the manager plays a key role in maintaining safety standards across clinical development programs.

• Manage clinical safety activities across Phase 1-4 trials, ensuring compliance with global regulatory requirements and internal SOPs.
• Collaborate with cross-functional teams and external partners (e.g., CROs, vendors) to ensure effective safety oversight and communication.
• Support the Clinical Safety Physician in the medical review of safety cases, including serious adverse events (SAEs), adverse events of special interest (AESIs), and pregnancy reports.
• Monitor and assess vendor performance in safety case processing, reporting, and compliance with contractual obligations.
• Prepare and distribute regular safety compliance and performance reports; coordinate issue resolution and necessary follow-up.
• Contribute to signal detection activities, periodic safety data reviews, and the development of aggregate safety reports.
• Review clinical trial and regulatory documents from a safety perspective, and support the development of key safety documents and plans (e.g., Safety Management Plans, SDEAs).
• Organize and participate in safety-related meetings, including DSMB and SRC meetings, and support risk-benefit assessments.
• Participate in audits and inspections, contribute to SOP development, and deliver training on safety procedures.
• Maintain accurate documentation and filing of safety-related records in compliance with regulatory and company standards

Requirements

• Bachelor's degree in Life Sciences or a related field required; medical or clinical background (e.g., pharmacy, nursing, MD) is a strong advantage
• At least 3 years of experience in clinical research, preferably with a focus on clinical safety or pharmacovigilance, including vendor oversight, case processing, or safety data review
• Experience in related areas (e.g., clinical development or regulatory affairs) with solid knowledge of clinical safety oversight may also be considered
• Familiarity with global safety and pharmacovigilance regulations (ICH-GCP, FDA, EMA), with knowledge of country-specific requirements (e.g., Latin America, Asia) considered a plus
• Experience with safety databases (e.g., Argus) and electronic data capture systems is an asset
• Proven ability to contribute to SOP and process development
• Strong organizational skills, high attention to detail, and ability to manage multiple priorities
• Excellent communication skills in English, both written and verbal
• Strong interpersonal and leadership skills, with the ability to work independently and in cross-functional teams

Benefits

Working with Valneva means being part of aglobal biotech companywith a clear vision to make a meaningfulimpact in the world. At Valneva, you can expect a dynamic andinnovativework environment characterized by an open, appreciative company culture and exciting,impactful assignments. Enjoy the benefits offlat hierarchies, an international atmosphere, and regular company events that fostercollaborationand connection.

Additionally, we offer:

• Work Life Balance:Flexitime & Compensation days
• Financial perks:Performance-related bonus & Lunch vouchers
• Lifelong learning:Unlimited access to LinkedIn Learning & German/English courses for free
• Health & Wellbeing:Free access to sports and fitness activities via myClubs& Office Massages

Join us and shape the future of biotechnology!

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 60.000 gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research

• Industries

  Non-profit Organizations and Primary and Secondary Education

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