Ana Erceg Email & Phone Number

Serbia

Belgrade, Serbia

Serbia

Key responsibilities:• Data and record management (ensuring all assigned records in global systems and databases are filled-out and regional records are set up correctly and in time), including but not limited to: -InSight: responsible for timely and accurate update of impact assessment for assigned CMC variations as well as update throughout submission and approval process (as applicable); responsible for timely and accurate update of actual submission and approval dates for… Show more Key responsibilities:• Data and record management (ensuring all assigned records in global systems and databases are filled-out and regional records are set up correctly and in time), including but not limited to: -InSight: responsible for timely and accurate update of impact assessment for assigned CMC variations as well as update throughout submission and approval process (as applicable); responsible for timely and accurate update of actual submission and approval dates for assigned Labeling variations (as applicable)-LIFT: responsible for timely impact assessment entry for assigned Labeling variations; timeline adjustments and extensions when applicable; set-up records for locally triggered changes as applicable. -For MEWA multi-country pack: set-up records for new Marketing authorization applications (MAA) and request reference country labeling designation for MEWA pack. -GRAIL: responsible for archiving all relevant HA communications related to the assigned submissions. • Using the E2E Dashboard and the CMC Visualization Dashboard for better overview of actions for assigned Labeling variation records and CMC variation events, respectively • Following-up with link between InSight and LIFT in terms of data accuracy for variations in scope of ERMC. • Submitting variation dossiers, including response to HA questions and eCTD closing sequences, in respective local HA portals, as applicable. • Ensuring Compliance and Audit readiness within own tasks considering all applicable Procedural Documents, including participating in audit-readiness activities. • Contributing to implementation of new Systems and Processes applicable to Data Management activities to ensure efficiency gains and to support Business Continuity. • Participating actively in internal process improvements. • Communicating effectively with other ERMC sub-teams and Stakeholders. Main mentoring activities for non EEA region. Show less

Serbia

• Providing strategic and operational regulatory activities - dossier's audit, preparation for submission MA Applications, handling documentation for renewal of existing Marketing Authorization. Organize documentation for variations and all other regulatory activities in order to secure that Agency submissions and approvals are in compliance with applicable regulatory requirements.• Preparation and maintenance of SmPC, PIL as well product labelling for Serbian market in cooperation with… Show more • Providing strategic and operational regulatory activities - dossier's audit, preparation for submission MA Applications, handling documentation for renewal of existing Marketing Authorization. Organize documentation for variations and all other regulatory activities in order to secure that Agency submissions and approvals are in compliance with applicable regulatory requirements.• Preparation and maintenance of SmPC, PIL as well product labelling for Serbian market in cooperation with local regulatory (ALIMS), medical and commercial contacts, including translation of text changes.• To assure implementation of artwork according to legal timelines by coordination with relevant partnersPlanning projects that are related to the company's business: contracting business activities with medical devices producers, undertaking all activities related to the fact that the medical device is launched on the market in accordance with the law and national guidelines. Managing marketing activities, market research, maintenance Marketing Authorization and distribution licence in accordance with Serbian low and related guidelines.Participating on tenders for medical gases and technical gases used in medical purpose, tenders related on cryomanagement, diagnostic tests and other medical devices. Experience in business with leading state institutions (Clinical centre of Serbia, Clinical centre of Vojvodina, The blood transfuzion Unit...) Show less

Serbia

SOL Group is a multinational chemical and pharmaceutical company operating in the Technical/Medical Gas business (brand “SOL”), in the Home Care Services (brand: "Vivisol”), in the Biotechnologies and Cryobiology with Diatheva and Cryolab.Project responsible for registration and distribution process; perform market analysis and identification of medical products from abroad manufacturing range with the aim of launching appropriate sales program in accordance with market needs. Key… Show more SOL Group is a multinational chemical and pharmaceutical company operating in the Technical/Medical Gas business (brand “SOL”), in the Home Care Services (brand: "Vivisol”), in the Biotechnologies and Cryobiology with Diatheva and Cryolab.Project responsible for registration and distribution process; perform market analysis and identification of medical products from abroad manufacturing range with the aim of launching appropriate sales program in accordance with market needs. Key responsibilities:- Providing strategic and operational regulatory activities in preparation of the submission and during the review of new Marketing Authorization Applications, variations and all other regulatory activities in order to secure Agency submissions and approvals in compliance with applicable regulatory requirements. Preparing the localized Product Information (Summary of Product Characteristics, label and leaflet) in collaboration with Agency for medicines and medical devices (ALIMS).- Fulfillment of all necessary activities aimed at acquiring a distribution license from relevant government institutions; securing required warehouse capacities and ensuring that all products are handled in a safe and efficient manner that meets GDP standards and ISO 9001. Responsible for preparation, implementation and development of SOP, Risk Management and Quality. SOL medical products: Oxygen, Nitrous oxide, Donopa, NeophyrLegal responsibilities:Responsible pharmacist (Quality, Distribution, Risk Management)Responsible person for vigilanceResponsible for submitted documentation during the registration process for medical products and medical devicesAs a lead figure in medical sector my obligations are also related to preparing a Business plan for the development of new projects, managing market presence and providing comprehensive product trainings. Show less

Serbia

• Responsible for the reception, storage and distribution of medicines, medical devices, dietetics and other general products. • Maintenance licenses for distribution - tracking, and reporting on the implementation legislation and all local regulations on medicines, medical devices and dietetics.• Responsibility for monitoring the quality of drugs and medical devices in wholesale• Record keeping and maintaining the QMS, in accordance with the guidelines of GDP• Monitoring and… Show more • Responsible for the reception, storage and distribution of medicines, medical devices, dietetics and other general products. • Maintenance licenses for distribution - tracking, and reporting on the implementation legislation and all local regulations on medicines, medical devices and dietetics.• Responsibility for monitoring the quality of drugs and medical devices in wholesale• Record keeping and maintaining the QMS, in accordance with the guidelines of GDP• Monitoring and reporting of adverse drug effects. Reporting doubts about the quality of the drug and medical devices, a deviation from the standard of medicine quality• Organization, implementation and evaluation of the initial and ongoing GDP staff training. • Communication with principals regarding orders¸planning, delivery and terms of delivery• Creating and maintenance SOPs to fulfill the requirement of GDP and other external demands from a partner (creation / updating, distribution)• Internal audits and reporting (GAP analysis) - conducting internal audits according to the plan and take the necessary corrective measures. Monitoring the implementation of preventive and corrective measures. • External audits – introducing distribution of medicines and MD in any segment of traffic, highlighting the benefits provided by the company system that during storage and transportation processes, risks are reduced to a minimum and therefore ensure that medicines reach their final destination at the prescribed conditions• Making decisions and coordination the processes of withdrawal of the drug from the market. Control repossessing medicines and medical devices, and making decisions about their re-release to the market.• Tracking movement towards the SAP• Active participation and discussion in working groups for the adoption and implementation of legislation in the Chamber of Commerce and Industry of Serbia - Pharmaceuticals Sector Show less

- Actively participating in the preparation of the all required documentation for submission to Regulatory bodies for the purpose of obtaining, renewing, amending and supplementing of marketing authorizations for medical products, devices and dietetics, as well as maintenance of all received licenses.- Monitoring and reporting on implementations of legislation and all local regulations for drugs, medical devices and dietetics.- Preparing of SmPC's, PIL, development and verification of… Show more - Actively participating in the preparation of the all required documentation for submission to Regulatory bodies for the purpose of obtaining, renewing, amending and supplementing of marketing authorizations for medical products, devices and dietetics, as well as maintenance of all received licenses.- Monitoring and reporting on implementations of legislation and all local regulations for drugs, medical devices and dietetics.- Preparing of SmPC's, PIL, development and verification of compliance packs for drugs, medical devices and dietetics in accordance with local regulations- Preparation of documents for the purpose of acquiring certificate of analysis for drugs and obtaining sanitary reports.- Participation in the composing promotional materials for medicines, medical devices and dietetics and compliance with local regulations. Show less

- Building and maintaining good business relationships with clinical doctors in the field of pediatrics, neonatology, dermo-cosmetics and with other health care professionals- Defining target products for designated consumer groups, identifying "opinion leaders" in that particular field and formulating lectures and trainings in accordance with demands from the field- Participating in important events and meetings, gathering relevant information with potential impact on the business… Show more - Building and maintaining good business relationships with clinical doctors in the field of pediatrics, neonatology, dermo-cosmetics and with other health care professionals- Defining target products for designated consumer groups, identifying "opinion leaders" in that particular field and formulating lectures and trainings in accordance with demands from the field- Participating in important events and meetings, gathering relevant information with potential impact on the business strategy and adapting it accordingly- Active participation in Detailing team which also includes marketing activities such as medical product positioning, contracting branding, tracking the competition’s overall activitiesCertificates and trainings:- Advanced sales skills (10 trainings in total)- Products training provided by all major principals Show less

- Working with patients, professional counseling and dispensing of medicines and medical supplies- Responsible for procurement of drugs and OTC medicines, as well as their reception and storage in accordance with relevant legislations- Monitoring and reporting of drugs with short shelf life

Serbia

- Working with patients, professional counseling and dispensing of medicines and medical supplies- Responsible for procurement of drugs and OTC medicines, as well as their reception and storage in accordance with relevant legislations- Working in galen laboratory. Medicines production intended for individual patients as well cosmetic preparations hand made manufacture and packaging.

Pharmacotherapy In Pharmacy

Master'S Degree, Pharmaceutical Sciences