Safety Assistant

작업 내용

Location: Belgium

Schedule: Permanent - Full Time - Office based

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Safety Assistant for one of the most innovative pharmaceutical company in the world, specialised in medical devices.
As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

Scope of the role:

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.

Main Job Tasks and Responsibilities:

This role will focus mainly on Intake activities and Vendor Oversight for COVID-19 Vaccine cases

Inbound and 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
• Verify and ensure translation of safety information
• Continual monitoring, assessing the reportability of ICSRs due for regulatory reporting, and submitting to respective Competent Authorities (CAs) / Business Partners (BPs)
• 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

Aggregrate Reporting

Support timely submission of aggregate safety reports (e.g. DSUR, PSUR etc. applicable) to applicable health authorities, in collaboration with local medical safety input

Compliance Monitoring

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

Audti/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

Education and Experience:

• A 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
• Computer literate with expert knowledge of the Intake (GIRS) and/or expedited reporting (OST) module(s)
• Knowledge and understanding of key legislation applicable to pharmacovigilance
• Proven expertise and experience in pharmaceutical regulations and R&D processes is desirable

Skills:

• Ability to prioritize and work to strict timelines daily
• Excellent verbal and written communication skills
• Ability to negotiate and communicate with internal and external customers
• Some flexibility in working hours is required
• Must be able to work on multiple simultaneous tasks with limited supervision
• Quick learner, motivated self-starter
• Excellent customer service, interpersonal, communication and team collaboration skills
• Able to follow change management for internal guidelines
• Fluency in English and Dutch (spoken and written)

The Benefits of Working for TalentSource in Belgium:

• Competitive Salary
• Group and hospitalisation insurance
• Electronic meal vouchers
• Internet reimbursement
• Company Car with fuel card depending on the function
• Dedicated Line Manager
• Regular face-to-face or phone meetings with line manager
• Full annual performance review process
• Ad-hoc team events and end of year party
• Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
• Employee satisfaction survey - your feedback is important for continuous improvement

The Application Process:

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002603

Who will you be working for?

About CROMSOURCE
CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences
TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.
CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Safety Specialist, Drug Safety, CAPA, Pharmacovigilance, Safety Case Reports, Adverse Events, Pharmaceuticals, Contract Research Organisation, CRO

Job Types: Full-time, Permanent

Benefits:

• Food allowance
• Internet reimbursement
• Work from home

Schedule:

• Monday to Friday

Supplemental Pay:

• 13th month salary
• Vacation money

Education:

• Bachelor’s (Preferred)

Language:

• Dutch (Required)
• English (Required)

Work Remotely:

• Temporarily due to COVID-19