Johnson & Johnson Careers
Drug Safety Specialist
Requisition ID: 1905719513W
Located in Warsaw
- Responsible for all stages of adverse event reporting for clinical study and post-marketing drugs and products. Accountable for collecting data, investigating facts and circumstances and reporting findings to appropriate stakeholders and regulatory agencies.
- Collects and records data and narratives regarding adverse events, particularly short and long-term effects, involving clinical study or post marketing drugs and products. Reviews and determines regulatory reporting requirements based on assessment of seriousness, causality and expectedness/listedness in accordance with regulatory guidelines and product labeling. Assigns codes to adverse events for input into appropriate database. Establishes adverse event files and tracking systems. Prepares adverse event reports for submission to regulatory agencies within the appropriate reporting timeframes. Verifies accuracy, completeness and validity of information for each report. Interacts with health professionals and consumers to obtain and follow up on reports of possible adverse events. Reviews cumulative safety data for submission to regulatory agencies. Classifies, tracks and documents potential adverse events which do not meet criteria for entry into database.
- Key responsibility is to ensure that systems and processes are available for collection (initial and follow-up), review, reporting and reconciliation of Adverse Events (AEs), Adverse Events combined with Product Quality Complaints (AE+PQCs) and pregnancy reports obtained through the following sources: spontaneous, solicited, clinical trials, data generating activities, local Regulatory Authorities (RAs) and all other potential sources.
- Manage and maintain active involvement in day-to-day AE reporting as applicable. (case registry, compliance with global organization requirements)
- Translation of ICSR, HA correspondence, regulatory intelligence, as required
Oversight and providing input
- Oversight of data generating activities to ensure any solicitation for information includes an appropriate review and reporting process for reporting potential AEs (e.g. patient support programs, market research surveys, internet sites), as applicable.
- Act as PV trainer for AE/PQC training for internal and external partners.
- Safety oversight of clinical projects conducted in the territory as applicable.
Clinical activities compliance
- Collaboration with Medical Affairs and Global Clinical Organization for the review and approval of safety aspects of local/global study protocols or Patient Support Programs (PSP) to ensure appropriate safety reporting to GMS or appropriate case management centre and RA, as required.
- Plan and ensure timely submission of Aggregate Reports according to local regulations.
- Provide local data as required to support the preparation of Aggregate Safety Summary reports (SUSAR LL, DSUR, etc.).
DECISION-MAKING AND PROBLEM-SOLVING:
- Application of clinical and regulatory judgment to the collection, review, follow up & submission of adverse event reports.
- Evaluation of local and global requirements to the design, implementation and maintenance of local processes.
- Technical evaluation of local regulatory and legal requirements to make determinations on notifications of changes to GMS.
- Evaluation of compliance and performance metrics to determine training needs and potential corrective actions required to maintain optimal performance.
- Medical or pharmaceutical sciences with proven expertise and experience in pharmaceutical regulations and R&D processes is preferred.
- By preference a minimum of 2 + years pharmaceutical industry experience with at least 1 year in a PV responsibility role.
- Sound knowledge of general medicine or pharmacy and clinical practice, or relevant scientific/medical field.
- Proven ability to organize workflow activities and manage multiple critical issues.
- Awareness of and familiarity with industry principles of PV, drug development and pharmacology.
- Expert knowledge of Global, Regional and Local PV Procedural Documents as applicable.
- Computer literate with knowledge of relevant IT safety systems.
- 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.
- Demonstrable knowledge of all local PV requirements and of global aspects of drug safety.
- Fluency in Polish and English language is required.
- An opportunity to be part of a global market leading company
- A dynamic and inspiring working environment
- Possibilities for further personal as well as professional development
- Motivating financial remuneration
- Numerous employee benefits
Janssen-Cilag Polska Sp. z o.o. (7824)
Drug & Product Safety Operations