{"id":6448,"date":"2019-09-05T16:14:01","date_gmt":"2019-09-05T16:14:01","guid":{"rendered":"http:\/\/www.clinres.si\/?page_id=6448"},"modified":"2025-11-23T16:32:18","modified_gmt":"2025-11-23T16:32:18","slug":"pharmacovigilance","status":"publish","type":"page","link":"https:\/\/www.clinres.si\/en\/services\/pharmacovigilance\/","title":{"rendered":"Pharmacovigilance"},"content":{"rendered":"[vc_row type=&#8221;full_width_background&#8221; full_screen_row_position=&#8221;middle&#8221; bg_image=&#8221;6473&#8243; bg_position=&#8221;center center&#8221; bg_repeat=&#8221;no-repeat&#8221; bg_color=&#8221;#ffffff&#8221; scene_position=&#8221;center&#8221; text_color=&#8221;light&#8221; text_align=&#8221;left&#8221; top_padding=&#8221;10%&#8221; bottom_padding=&#8221;15%&#8221; color_overlay=&#8221;#000000&#8243; overlay_strength=&#8221;0.5&#8243; enable_shape_divider=&#8221;true&#8221; shape_divider_color=&#8221;#ffffff&#8221; shape_divider_position=&#8221;bottom&#8221; shape_divider_height=&#8221;100&#8243; bg_image_animation=&#8221;none&#8221; parallax_bg=&#8221;true&#8221; parallax_bg_speed=&#8221;fast&#8221; shape_type=&#8221;mountains&#8221;][vc_column column_padding=&#8221;no-extra-padding&#8221; column_padding_position=&#8221;all&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_link_target=&#8221;_self&#8221; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; width=&#8221;1\/1&#8243; tablet_width_inherit=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; bg_image_animation=&#8221;none&#8221;][vc_row_inner equal_height=&#8221;yes&#8221; content_placement=&#8221;middle&#8221; column_margin=&#8221;default&#8221; text_align=&#8221;left&#8221;][vc_column_inner column_padding=&#8221;no-extra-padding&#8221; column_padding_position=&#8221;all&#8221; background_color_opacity=&#8221;1&#8243; 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column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; bg_image_animation=&#8221;none&#8221; enable_animation=&#8221;true&#8221; animation=&#8221;fade-in&#8221; offset=&#8221;vc_col-lg-6 vc_col-md-6 vc_col-xs-12&#8243;][vc_column_text css_animation=&#8221;fadeInUp&#8221; css=&#8221;.vc_custom_1567700055423{margin-bottom: 15px !important;}&#8221;]\n<h5>Services<\/h5>\n[\/vc_column_text][split_line_heading]\n<h2>Pharmacovigilance<\/h2>\n[\/split_line_heading][\/vc_column_inner][vc_column_inner column_padding=&#8221;padding-6-percent&#8221; column_padding_position=&#8221;bottom&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; width=&#8221;1\/4&#8243; tablet_width_inherit=&#8221;default&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; bg_image_animation=&#8221;none&#8221; enable_animation=&#8221;true&#8221; 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phone_text_alignment=&#8221;default&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; bg_image_animation=&#8221;none&#8221;][page_submenu alignment=&#8221;center&#8221; sticky=&#8221;true&#8221;][page_link link_url=&#8221;\/en\/services\/clinical-trial-services\/&#8221; title=&#8221;Clinical Trial Services&#8221; id=&#8221;1763915520522-5&#8243; tab_id=&#8221;1763915520522-6&#8243;][vc_column_text][\/vc_column_text][\/page_link][page_link link_url=&#8221;\/en\/services\/regulatory-affairs-services\/&#8221; title=&#8221;Regulatory Affairs Services&#8221; id=&#8221;1763915520565-6&#8243; tab_id=&#8221;1763915520565-0&#8243;][vc_column_text][\/vc_column_text][\/page_link][page_link title=&#8221;Pharmacovigilance&#8221; id=&#8221;1763915520586-1&#8243; link_url=&#8221;\/en\/services\/pharmacovigilance\/&#8221; tab_id=&#8221;1763915520587-10&#8243;][\/page_link][page_link title=&#8221;Quality assurance&#8221; id=&#8221;1763915520609-7&#8243; link_url=&#8221;\/en\/services\/quality-assurance\/&#8221; tab_id=&#8221;1763915520609-2&#8243;][\/page_link][page_link title=&#8221;Medical Devices Support&#8221; id=&#8221;1763915520630-3&#8243; link_url=&#8221;\/en\/services\/medical-devices-support\/&#8221; tab_id=&#8221;1763915520631-1&#8243;][\/page_link][page_link title=&#8221;Other services&#8221; id=&#8221;1763915520652-1&#8243; link_url=&#8221;\/en\/services\/other-services\/&#8221; tab_id=&#8221;1763915520652-6&#8243;][\/page_link][page_link title=&#8221;GMP\/GDP Services&#8221; id=&#8221;1763915523339-5&#8243; tab_id=&#8221;1763915523341-6&#8243; link_url=&#8221;https:\/\/www.clinres.si\/en\/services\/gmp-and-gdp-services\/&#8221;][\/page_link][\/page_submenu][\/vc_column][\/vc_row][vc_row type=&#8221;full_width_background&#8221; full_screen_row_position=&#8221;middle&#8221; scene_position=&#8221;center&#8221; text_color=&#8221;dark&#8221; text_align=&#8221;left&#8221; top_padding=&#8221;7%&#8221; bottom_padding=&#8221;7%&#8221; overlay_strength=&#8221;0.3&#8243; shape_divider_position=&#8221;bottom&#8221; bg_image_animation=&#8221;none&#8221;][vc_column column_padding=&#8221;padding-2-percent&#8221; column_padding_position=&#8221;all&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_link_target=&#8221;_self&#8221; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; width=&#8221;1\/2&#8243; tablet_width_inherit=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; bg_image_animation=&#8221;none&#8221;][vc_column_text]\n<h2>Pharmacovigilance<\/h2>\n[\/vc_column_text][team_member image_url=&#8221;6785&#8243; team_memeber_style=&#8221;meta_below&#8221; link_element=&#8221;none&#8221; color=&#8221;Accent-Color&#8221; name=&#8221;Jana Dragojevi\u010d, MPharm, PhD&#8221; job_position=&#8221;Head of Pharmacovigilance Department&#8221;][vc_column_text]\n<p class=\"lead\">Our Pharmacovigilance professionals offer PVG support, which can include global and\/or local PV services.<\/p>\n[\/vc_column_text][\/vc_column][vc_column column_padding=&#8221;padding-2-percent&#8221; column_padding_position=&#8221;all&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_link_target=&#8221;_self&#8221; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; width=&#8221;1\/2&#8243; tablet_width_inherit=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; bg_image_animation=&#8221;none&#8221;][toggles style=&#8221;minimal&#8221;][toggle color=&#8221;Default&#8221; title=&#8221;PV for Marketed Products&#8221;][vc_column_text]<strong>Our services include:<\/strong><\/p>\n<ul>\n<li>Provision of qualified PV personnel (including QPPV, QPPV deputy, local PV contact, and medically qualified staff)<\/li>\n<li>Establishment and maintenance of PV systems<\/li>\n<li>Development and maintenance of Pharmacovigilance System Master Files (PSMF)<\/li>\n<li>Development and maintenance of Standard Operating Procedures (SOPs)<\/li>\n<li>Global and local literature monitoring<\/li>\n<li>Management of Individual Case Safety Reports (ICSRs)<\/li>\n<li>Generation and submission of aggregate safety reports<\/li>\n<li>Development and maintenance of Risk Management Plans (RMPs)<\/li>\n<li>Signal management<\/li>\n<li>Management of Direct Healthcare Professional Communications (DHPCs)<\/li>\n<li>Management of Risk Minimization Measures (RMMs)<\/li>\n<li>Monitoring of regulatory intelligence<\/li>\n<li>Electronic reporting of Individual Case Safety Reports (ICSRs)<\/li>\n<li>XEVMPD data management<\/li>\n<li>Audit and inspection readiness<\/li>\n<li>Pharmacovigilance training for both PV and non-PV personnel<\/li>\n<li>Management of pharmacovigilance agreements<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>We also offer pharmacovigilance support for veterinary medicinal products.[\/vc_column_text][\/toggle][toggle color=&#8221;Default&#8221; title=&#8221;PV for Clinical Trials&#8221;][vc_column_text]Clinres Farmacija offers complete drug safety development services during clinical trials including:<\/p>\n<ul>\n<li>Service of experienced professionals (responsible person for pharmacovigilance, and back-up),<\/li>\n<li>Registration with Eudravigilance Clinical Trial Module,<\/li>\n<li>Establishment of Standard Operating Procedures (SOPs) on clinical trial pharmacovigilance and other controlled quality documents,<\/li>\n<li>Management of cases and case processing (SAE),<\/li>\n<li>SAE medical review, MedDRA coding,<\/li>\n<li>Safety data reconciliation,<\/li>\n<li>Preparation and submission of Development Safety Update Reports,<\/li>\n<li>Preparation and submission of periodic SUSAR reports,<\/li>\n<li>Electronic reporting of Suspected Unexpected Serious Adverse Events (SUSARS),<\/li>\n<li>Reporting to Regulatory Authorities and Ethics Committees as appropriate,<\/li>\n<li>Supporting assessment of risk-benefit ratios throughout the trial and updating the Investigator Brochure as necessary,<\/li>\n<li>Developing of risk management plans in full compliance with regulations.<\/li>\n<\/ul>\n<p><strong>\u00a0<\/strong><br \/>\nWe offer dedicated phone and fax lines which enable you to personally contact a safety officer.[\/vc_column_text][\/toggle][\/toggles][\/vc_column][\/vc_row]\n","protected":false},"excerpt":{"rendered":"<p>[vc_row type=&#8221;full_width_background&#8221; 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