Clinical Safety Manager (m/f/d)
- Wien
- € 60.000 pro Jahr
- Unbefristet
- Vollzeit
- 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.
- 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
- 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