Job Description<\/p>\n
\tThis is a temporary role for a 9 months duration.
\n\tAs the Pharmacovigilance (PV) Specialist, you will be responsible for specified PV activities (as delegated\/assigned by your manager) and are able to perform these tasks with minimal supervision. You will also be responsible for ensuring adherence to all applicable regulations, company policies and procedures.<\/p>\n
The items listed below are activities that can be performed by the role as assigned by the manager and are applicable for all supported countries.<\/p>\n
\tResponsible for execution of local PV processes and activities in collaboration with applicable internal functional areas and external parties, ensuring alignment with local legislation and local\/regional\/global company procedures and policies. Activities may include but are not limited to management and negotiation of local PV agreements, local due diligence activities, Post approval Safety Monitoring Program (PSMP) implementation, scheduling and coordinating aggregate safety report submissions, conducting local training, review of local initiatives for compliance with PV requirements, communication of safety issues.
\n\tResponsible for execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned.
\n\tResponsible for day-to-day adverse events case management which may include case intake, translations (English and\/or local language (as applicable)), acknowledgments, follow-up and submission activities in accordance with PV procedures and country regulations.
\n\tSupports local PV, business partner and vendor audits and inspections including readiness activities, document requests and CAPA activities.
\n\tParticipates in issue management\/compliance activities and coordinates \/ prepares the necessary local corrective actions.
\n\tSupports development and maintenance of local PV procedures and controlled documents in compliance with local, regional and global standards, to ensure global quality PV data.
\n\tSupports PV self-inspections as required by PV Legislations (where applicable).
\n\tMay be assigned responsibility for ensuring appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally as per department policy and local legislations.
\n\tPrepare\/maintain\/submit local RMPs to the local HA (as applicable).
\n\tMay be responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable).
\n\tSupport local implementation of applicable business continuity plans
\n\tResponsible for filing, storage and archiving of safety-related documentation in accordance with company policies and local requirements.
\n\tServes as local Subject Matter Expert on relevant PV regulations, processes, and procedures.\u00a0
\n\tTranslates or QCs translation of applicable PV documents.
\n\tSupports PV Lead in maintaining the local PV Training matrix and onboarding plans.
\n\tMay be responsible for reviewing, providing input and approving local initiatives (e.g., digital interfaces, marketing initiatives\/ patient programs, organized data collection systems, etc.), and other programs to ensure compliance with PV requirements, as applicable
\n\tMay be responsible for Health Authority Website Monitoring for potential safety issues, safety alerts, and new\/revised PV requirements in compliance with company procedures and local legislation (as applicable).
\n\tLiaises with the local business units to keep them apprised of safety activities and provides input on strategic decisions.
\n\tRepresents PV in cross-functional organizational and alliance partner forums as needed.
\n\tParticipates on local company committees and councils for matters impacting PV as assigned. 21. Participates in special projects or rotational assignments within or outside of IPV as part of their professional development.
\n\tResponsible for completing all required\/applicable trainings assigned at time of hire and after hire, by the due dates and before performing the activity.<\/p>\n
Education:<\/p>\n
\tHealth, life science, or medical science degree or equivalent by education\/experience<\/p>\n
Work Experience:<\/p>\n
\tAt least 1 year of PV experience in the pharmaceutical industry is preferred.
\n\tGeneral knowledge of AE reporting requirements and relevant PV regulations<\/p>\n
Job-specific competencies & skills:<\/p>\n
\tMust be fluent in English (written and spoken) while proficient in local language.
\n\tDemonstrates proficiency in communication, organizational, and time management skills.
\n\tAbility to work in partnership with others (internally and externally).
\n\tAbility to interface broadly\u202fwith colleagues within related functions and cross-functionally and be able to work independently with no supervision except in the most complex of situations.\u202f
\n\tDemonstrates skills to drive change that enhances processes within the company or cross-functionally that improve quality and \/or add value to the business.<\/p>\n
Apply via company website ( ) or<\/p>\n
msd-editor.phenompro.com<\/p>\n
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