Local Safety Specialist (f/m) Job

Job description

Local Safety Specialist (f/m)-1500069787WDescriptionAt Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson.
As a Local Safety Specialist (LSS) you will:
- Have primary responsibility for supporting the coordination of safety reporting requirements as required for Marketing Authorization Holders (MAH) and/or study sponsor, as applicable
- Provide direct support to the Country Safety Team Lead (CSTL) e.g by reviewing local Medical/Scientific Literature in order to identify and report AEs as required per literature reporting criteria
- Be responsible for all pharmacovigilance activities in absence of the CSTL.
- Responsible for the collection, review and reporting of Adverse Events (AEs), AEs combined with Product Quality Complaints (AEs +PQCs) and pregnancy reports
- Assist in the implementation of compliance standards (SOPs) and facilitate the collection of compliance metrics as required
- Ensure availability as back-up for business and non-business hours contact
- Ensure that day-to-day Pharmacovigilance (PV) functions are performed satisfactorily and that full regulatory compliance is maintained at the Janssen Local Operating Company level
- Share with the internal stakeholders comprehensive PV requirements to achieve Local Operating Company compliance
- Coordinate the delivery of a comprehensive PV service and maintain standards for regulatory reporting requirements
- Undertake site visits for special interest cases
- Support the Local Safety Officer (LSO) to undertake local review of and ensure the submission of aggregate reportsQualifications
- Minimum 2 years Drug Safety experience within a pharmaceutical, clinical or healthcare setting and a sound knowledge of general medicine, pharmacy, or clinical practice (pharmacist, biologist, nurse)
- Pharmaceutical industry awareness and strong knowledge of Drug Safety Systems
- Strong experiences in handling inbound and outbound case reporting (spontaneous and solicited)
- Experience in working with medical affairs project teams
- Experience in providing PV training to internal and external stakeholders
- Strong interpersonal and communication skills and the ability to influence cross-functional teams
- Resilience and the ability to prioritize in times of time pressure
- Excellent German language skills and fluency in English language (both, in writing and speaking)The well-being and development of our employees are central aspects of our company creed. Individuals who would like to fully realize their potential as part of our international, innovation-driven corporate family and who aspire to have challenging work, will find that our company provides just the right conditions. We consider intensive initial training, further education that is tailored to our employees' work, and excellent opportunities for development – both nationally and internationally – to be just as essential as a good work-life balance, attractive compensation and above-average employee benefits. One aspect that distinguishes our company is the large number of measures we have to support our trainees and promote career development in ways that are also compatible with family life.
Minimum annual gross salary: 51.000 EUR (excl. of variable portion). Overpayment depending on professional qualification and experience.
Primary Location:Europe/Middle East/Africa-Austria-ViennaOrganization: Janssen Cilag Pharma GmbH (8558)Job Function: Pharmacovigilance