At 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. Please visit www.janssen.com for more information.
Local Safety Specialist will be responsible for:
- Ensuring Individual Case Safety Report (ICSR) case processing and related activities are carried out to enable compliance with applicable regulatory requirements, company procedures, at a local/regional level or global level, and in compliance with provisions of PV agreements with business partners.
- The scope of support is primarily focused on countries. The role holder may be expected to support and ensure case management and related activities for other countries within the EMEA Region (centralized case management) are carried out in a timely manner.
The responsibilities & the impact YOU will have:
- Receipt, assessment and processing of incoming safety information from multiple sources, both internal and external to the Company.
- Enter relevant/required safety data into the Global Inbound Receipt System (GIRS) from spontaneous, clinical trials and other solicited sources.
- Provision of safety information/acknowledgements to marketing partners/other third-party partners/Global Medical Safety within the internal and contractual timelines.
- Data entry for complex cases (seek support from senior specialist as applicable)
- Performing follow-up for requesting additional information from multiple sources.
- Assist in the quality review of data captured in the GIRS as applicable
- Verify and ensure translation of safety information, if applicable.
- Continual monitoring, assessing the reportability of ICSRs due for regulatory reporting, and submitting to respective Competent Authorities (CAs) / Business Partners (BPs), as applicable.
- Enable mechanisms to support LSO oversight for case management activities as applicable. e.g. escalation non-conformance in a timely manner.
- Liaise with applicable stakeholder to support case processing requirements for Medical device vigilance, materiovigilance, or cosmetovigilance (as applicable).
- Support timely submission of aggregate safety reports (e.g. DSUR, PSUR etc. applicable) to applicable health authorities, in collaboration with local medical safety input (as applicable).
- Ensure accurate and timely documentation of deviations to process/timelines, including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs) as applicable.
- Support the LSO, in matters pertaining to audit or inspection preparation or conduct.
- Ensure and support other case management related activities such as:
- Vendor training, on-going vendor support on a case level (daily or as required), case review, and vendor oversight (daily or as required)
- Local literature screening for ICSRs and potential safety signals (in consultation with local medical safety as needed).
- Periodic reconciliation activities
- Support IPV Case Management Team Lead / LSO in responding to ad hoc requests (e.g. regulatory authority requests) as required.
- Support case management related innovation roll-out, in collaboration with the IPV Case Management Regional and Team leads
- Support the coordination and process standardization efforts to cross-country collaboration with regards to case management activities, as applicable
- Write or review ICSR related procedural documents and local memo implementation as applicable.
- Support critical project works
- We would love to hear from YOU, if you have:
- Degree in life, health or pharmaceutical sciences is preferred
- Proficiency in Medical terminology (local languages).
- Familiarity with global ICSR related global, regional and local PV procedural documents as applicable.
- Computer literate with expert knowledge of the Intake (GIRS) and/or expedited reporting (OST) module(s)
- Ability to prioritize and work to strict timelines daily
- Excellent verbal and written communication skills
- Fluency in Polish and English language required
- Ability to negotiate and communicate with internal and external customers
- Knowledge and understanding of key legislation applicable to pharmacovigilance within
- Minimum 2 year of proven expertise and experience in pharmaceutical regulations and R&D processes is desirable
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 ambitious projects and assignments
- Possibilities for development on personal and professional level
Employee benefits are regulated by an internal policy that contains full details regarding the entitlement and conditions for the benefits.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, or national origin and will not be discriminated against on the basis of disability.