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Local Safety Officer (m/f/d) Pharmacovigilance

Local Safety Officer (m/f/d) Pharmacovigilance

As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it.

The Local Safety Officer (m/f/d) ensures that the LOC product activities are managed in compliance with the local regulations and company policies/procedures at a local, regional and global level and in accordance with any product vigilance agreements with third party business partner and have an appropriate system of the pharma and consumer product vigilance and Risk Management in place to assure appropriate oversight for products within its responsibility.

This position will be based in Vienna, Austria and can work from home up to two days/week.

The responsibilities & the impact YOU will have:
* Act as LSO for Janssen-Cilag medicinal products and Johnson & Johnson Consumer products (OTC medicinal products, Consumer medicinal devices and cosmetics)
* Act as local contact person for pharmacovigilance and provide regular training on pharmacovigilance to Johnson & Johnson/Janssen-Cilag employees
* Ensure that local PV activities (including adverse event reporting) are handled in compliance with all company requirements and policies, local legislation, and in accordance with all PV agreements with third party business partners
* Having an appropriate system of PV and risk management in place in order to assure appropriate oversight for products
* Involvement in implementation of Risk Management Plans (RMPs) and Urgent Safety Restrictions
* Take appropriate measures to ensure that new safety information is available to Health Care Professionals (HCPs) in a timely manner, if applicable
* Maintain overall responsibility for the coordination of safety requirements as delegated by Marketing Authorization Holder
* ICSR management activities as appropriate
* Oversight of data generating activities to ensure any solicitation for information including an appropriate review and reporting process for reporting potential Aes (e.g. patient support programs, market research surveys, internet sites) as applicable
* Assure all vendor contracts have appropriate Pharmacovigilance language incorporated and that these contracts are archived in the global system as applicable
* Collaborate with local stakeholders to ensure safe and proper use of our products
* Where applicable, support the QPPV to provide safety-related regulatory communication.
* Have sufficient competencies to influence the implementation of a system for quality and activity of pharmacovigilance
* Support audits/inspections as required
* Ensure awareness of changes in regulations which may have an impact on PV activities and responsibilities. Evaluate the impact on local processes and inform the appropriate global and regional groups of any changes to local laws and regulations regarding PV


We love to hear from YOU, if you have:
* Medical or pharmaceutical sciences (general medicine, pharmacy, clinical practice) with proven expertise and experience in Austrian pharmaceutical regulations (pharmacovigilance, drug development, pharmacology)
* Minimum of 2 + years pharmaceutical industry experience with at least 1 year in a pharmacovigilance role
* Degree qualified ideally in life sciences, chemistry, chemical engineering
* Expert knowledge of Global Regional and Local Pharmacovigilance Procedural Documents as applicable and knowledge of local pharmacovigilance requirements and global aspects of drug safety
* Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external customers. Ability to establish and maintain open relationships within the organization and with authorities
* Strong organizational skills, attention to details and accuracy
* Proven ability to manage projects as assigned and work unsupervised
* Fluent in German and English language is required
* Travel within GSA up to 10%

This is what awaits YOU at J&J:
* An opportunity to be part of a global market leader
* A dynamic and inspiring working environment
* Many opportunities to work on challenge projects and assignments
* Possibilities for further personal as well as professional development
* Various employee & social benefits

For this position we offer a gross annual salary starting at EUR 85.000 (plus variable components and benefits). The willingness to overpay, depending on professional qualifications and experience, is given.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspective and life experiences.

That is why we in Johnson & Johnson are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential no matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means " You Belong"!
Primary Location
Janssen Cilag Pharma GmbH (8558)
Job Function
Requisition ID

Über dieses Unternehmen

Johnson & Johnson Gesellschaft m.b.H.

Vorgartenstraße 206b
1020 Wien

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Über diesen Job

Local Safety Officer (m/f/d) Pharmacovigilance



Marketing | Werbung




1 Job

Local Safety Officer (m/f/d) Pharmacovigilance

bei Johnson & Johnson Gesellschaft m.b.H.

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