IPV Case Management Specialist Poland - 2406201379W

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and where solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/

For Johnson & Johnson Poland, we are looking for an IPV Case Management Specialist to be based in our Warsaw office. This role will work in a hybrid model.

Role Summary

The International Pharmacovigilance (IPV) Case Management Specialist is responsible for ensuring Individual Case Safety Report (ICSR) case processing and related activities are carried out to enable compliance with applicable regulatory requirements, and company procedures, at a local/regional level or global level, and in compliance with provisions of PV agreements with business partners.

Principal Responsibilities

• 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.

• Performing follow-up for requesting additional safety information.

• Enable mechanisms to support LSO oversight for case management activities

• Support timely submission of aggregate safety reports (e.g. DSUR) to applicable Health Authorities, in collaboration with local medical safety input.

• Ensure accurate and timely documentation of deviations to process/timelines, including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs)

• Support the LSO, in matters pertaining to audit or inspection preparation or conduct.

• Vendor oversight, training, and support on a case level (as required)

• Periodic reconciliation activities

• Support case management-related innovation roll-out, in collaboration with the IPV Case Management Regional and Team leads

Qualifications

Education and Experience requirements

Academic qualification

A degree or equivalent experience in life, health, or pharmaceutical sciences is preferred.

Essential knowledge & skills

• 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) 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

• Proven expertise and experience in pharmaceutical regulations and R&D processes are desirable

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Primary Location Europe/Middle East/Africa-Poland-Mazowieckie-Warsaw

Organization Janssen-Cilag Polska Sp. z o.o. (7824)

Job Function Pharmacovigilance

Req ID: 2406201379W