Ivan Colic Email & Phone Number

Croatia

Zagreb, Croatia

Croatia

Zagreb, Croatia

Zagreb, Grad Zagreb, Croatia

Zagreb, Croatia

Principal Responsibilities:• Ensuring that all contracted activities performed on behalf of clients are delivered on time with good quality and in compliance with the applicable regulatory requirements.• Ensures MI systems are functioning and validated• Oversees quality of MI Services provided For the Client:• Participate in the monthly quality and compliance management review of enquiries;• Review and approve client Monthly Reports;• Oversee service provided to… Show more Principal Responsibilities:• Ensuring that all contracted activities performed on behalf of clients are delivered on time with good quality and in compliance with the applicable regulatory requirements.• Ensures MI systems are functioning and validated• Oversees quality of MI Services provided For the Client:• Participate in the monthly quality and compliance management review of enquiries;• Review and approve client Monthly Reports;• Oversee service provided to client and ensure delivery of a high quality service;• Actively participate in client audits and inspections where there is an MI involvement;• Prepare audit responses• Oversight of corrective and preventative actions (CAPAs) for each MI client and management/maintenance of a centralised tracking system to ensure adequate documentation and closeout of client CAPAs.Advising on/reviewing clients Medical Information systems, as appropriate; For the Company:• Train, mentor and line manage medical information individuals and manage their on-going evaluation and periodic appraisals;• Identify areas of improvement for current processes;• Assist with the development, review and improvement of medical information processes and procedures• Prepare monthly Quality and Compliance metrics for medical information for review by Head of Medical Information• Develop and manage medical information call centre to a high standard to ensure regulatory compliance and client satisfaction;• Assist in departmental regulatory inspection preparedness for the company pharmacovigilance system and actively participating in PV inspections or auditsOversight of Medical Information Query Management System (MIQMS) and relevant upgrades that may impact the system;• Assist in validation activities of resources used within Medical Information Department (MIQMS, Call management system, etc.)• Act as Medical Information Administrator of the MIQMS• Part of back-up for the Head of Medical Information Show less

Zagreb, Croatia

- Provide labelled and unlabelled medical/safety information responses in accordance with regulatory requirements, industry standards, and client and PrimeVigilance internal policies and procedures;- Accurately identify, document and report adverse events, pregnancy and other special situation events, and product quality complaints in a clear and concise manner;- Participation in the monthly quality and compliance management review of enquiries;- Participation and coordination of… Show more - Provide labelled and unlabelled medical/safety information responses in accordance with regulatory requirements, industry standards, and client and PrimeVigilance internal policies and procedures;- Accurately identify, document and report adverse events, pregnancy and other special situation events, and product quality complaints in a clear and concise manner;- Participation in the monthly quality and compliance management review of enquiries;- Participation and coordination of updates to Frequently Asked Questions and Standard Response Documents;- Oversight the management of the medical information content library of client information used to answer medical information enquiries;- Preparation of responses to enquiries based on researching literature and collaboration with physicians both internally and with client internal departments;- Manage client medical information project and attendance of client operational meetings - Development and maintaining of literature search strings based on client requirements;- Preparation and maintaining of client Joint Operating Guidelines;- Direct line-manage medical information individuals and management of their on-going evaluation and periodic appraisals;- Oversight of handling and management of medical enquiries;- Providing guidance and support with enquiry escalations and non-standard enquiries;- Training and mentoring direct line reports and wider medical information team;- Assisting with the development and improvement of medical information processes and procedures;- Preparation of monthly Quality and Compliance metrics for medical information;- Attendance of relevant courses or conferences for the purpose of continued professional development;-Partaking in departmental regulatory inspection preparedness for the company pharmacovigilance system and actively participating in PV inspections or audits.-Support and deputise for the Medical Information Manager Show less

Zagreb, Croatia

- Provide labelled and unlabelled medical/safety information responses in accordance with regulatory requirements, industry standards, and client and PrimeVigilance internal policies and procedures;- Accurately identify, document and report adverse events, pregnancy and other special situation events, and product quality complaints in a clear and concise manner;- Participate in the quality and compliance based peer review of enquiries;- Participate in the update of Frequently Asked… Show more - Provide labelled and unlabelled medical/safety information responses in accordance with regulatory requirements, industry standards, and client and PrimeVigilance internal policies and procedures;- Accurately identify, document and report adverse events, pregnancy and other special situation events, and product quality complaints in a clear and concise manner;- Participate in the quality and compliance based peer review of enquiries;- Participate in the update of Frequently Asked Questions and Standard Response Documents for clients who have contracted such service;- Oversee the management of the medical information content library of client information used to answer medical information enquiries ;- Prepare responses to enquiries based on researching literature and collaboration with physicians both internally and with client internal departments, if applicable;- Participate in the out-of-hours provision of medical information - Lead client medical information day to day operational activities;- Review and approve client monthly enquiry line listing and enquiry summary reports;- Development and maintaining of literature search strings based on client requirements;- Preparation and maintaining of client Joint Operating Guideline document;- Oversight of handling and management of medical enquiries;- Providing guidance and support with enquiry escalations and non-standard enquiries;- Identify areas of improvement for current processes;- Assisting with the development medical information processes and procedures and;- Partaking in departmental regulatory inspection preparedness for the company pharmacovigilance system and actively participating in PV inspections or audits.-Support and deputise for the Senior Medical Information Officer Show less

Zagreb, Croatia

-Provide labelled and unlabelled medical/safety information responses in accordance with regulatory requirements, industry standards, and client and PrimeVigilance internal policies and procedures;- Accurately identify, document and report adverse events, pregnancy and other special situation events, and product quality complaints in a clear and concise manner;-Performing follow-up with enquirers at request of clients-Ensure that all assigned medical information enquiries managed… Show more -Provide labelled and unlabelled medical/safety information responses in accordance with regulatory requirements, industry standards, and client and PrimeVigilance internal policies and procedures;- Accurately identify, document and report adverse events, pregnancy and other special situation events, and product quality complaints in a clear and concise manner;-Performing follow-up with enquirers at request of clients-Ensure that all assigned medical information enquiries managed are fully documented within the Medical Information database- Participate in the quality and compliance based peer review of enquiries;- Participate in the update of Frequently Asked Questions and Standard Response Documents for clients who have contracted such service;- Oversee the management of the medical information content library of client information used to answer medical information enquiries ;- Prepare responses to enquiries based on researching literature and collaboration with physicians both internally and with client internal departments, if applicable;- Participate in the out-of-hours provision of medical information - Assist in the organization of medical information day to day operational activities;- Providing regular updates regarding project status and metrics concerning enquiries;- Identify areas of improvement for current processes;- Assist in departmental regulatory inspection preparedness for the company pharmacovigilance system and actively participating in PV inspections or audits. Show less

Zagreb, Croatia

-Handling medical information enquiries in both English and German; -Providing approved responses to medical enquiries from external customers including healthcare professionals and patients as well as assisting the pharmaceutical clients’ internal departments with queries where required. This includes acting as a call handling agent as part of the Medical Information dedicated call center; -Ensuring that all medical information enquiries are tracked and fully documented within the… Show more -Handling medical information enquiries in both English and German; -Providing approved responses to medical enquiries from external customers including healthcare professionals and patients as well as assisting the pharmaceutical clients’ internal departments with queries where required. This includes acting as a call handling agent as part of the Medical Information dedicated call center; -Ensuring that all medical information enquiries are tracked and fully documented within the Medical Information database; -Helping to maintain the library of reference safety information (e.g., CCDS, SmPCs, PI, etc.) within the Medical Information database; -Helping to maintain the library of Frequently Asked Questions and Standard Response Documents within the Medical Information database; -Ensuring that potential Adverse Events and Product Quality Complaints are documented in the Medical Information database and forwarded for appropriate processing; -To translate received information into English, if applicable; -Participating in the out-of-hours provision -Conducting and tracking of local language medical literature screening Show less

Zagreb, Croatia

-Participating in weekly and ad hoc literature screening activities to identify potential ICSRs and other safety related information pertaining to nominated products-Maintaining a record and tracking all literature abstracts screened and full literature articles reviewed, with actions taken and the reason-Forwarding any ICSRs to PV Associates for data entry into the global drug safety database-Filing other relevant safety related information for use in signal detection and… Show more -Participating in weekly and ad hoc literature screening activities to identify potential ICSRs and other safety related information pertaining to nominated products-Maintaining a record and tracking all literature abstracts screened and full literature articles reviewed, with actions taken and the reason-Forwarding any ICSRs to PV Associates for data entry into the global drug safety database-Filing other relevant safety related information for use in signal detection and PSURs-Conducting and tracking of local language medical literature screening Show less