Johnson & Johnson
BE - International Pharmacovigilance Case Management Specialist
Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.
Currently we are looking for an International Pharmacovigilance Case Management Specialist.
This is a part time position for 20 hours per week. Working schedule is still negotiable.
- 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 specific countries, however 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.
INBOUND & OUTBOUND ICSR CASE MANAGEMENT
- 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.
AUDIT / INSPECTION PREPARATION AND SUPPORT
- 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.
DECISION-MAKING AND PROBLEM-SOLVING:
- Collaborate with other IPV Case Management Specialists, IPV Case Management Team Leads, IPV Case Management Regional Lead, case processing SMEs in GMS/OCMS, local medical safety medical team and IPV Affairs, in addressing internal and external ICSR related queries.
- Advise the IPV Case Management Team Lead in making IPV case management related decisions of a local, regional or global impact as applicable.
The IPV Case Management Specialist is an employee of IPV. IPV is part of GMS (Global Medical Safety).
- Components of the IPV Case Management Specialist role may be delegated/backed-up by other Specialists within a country or collaboration network (as applicable).
- IPV Case Management Specialist may also act as back-up for the IPV Case Management Team Lead if necessary.
EDUCATION & EXPERIENCE REQUIREMENTS:
- A bachelor or master degree 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) and/or expedited reporting (OST) module(s).
- Ability to prioritize and work to strict timelines daily.
- Excellent verbal and written communication skills.
- Fluency in Dutch and English language required. Good basic undestanding of French is a plus.
- Ability to negotiate and communicate with internal and external customers.
- Knowledge and understanding of key legislation applicable to pharmacovigilance.
- Proven expertise and experience in pharmaceutical regulations is desirable.
- Flexible working hours.
- Because of COVID-19, you will work fulltime from home.
- When we can go back onsite, you are expected 2 days in Beerse and 1 day in Breda.
- This is a long term contracting position, with the possibility of an extension after the end date. You wil receive a contract via our partner Randstad Professionals. They can offer you a contract of indefinite duration, a project contract for the duration of the assignment at J&J or a freelance contract.