IQVIA

PV Safety Specialist

IQVIA • $80K — $106K *
Mississauga, ON L4T 0A1In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 5+ years of experience in pharmacovigilance or related field
  • Fluency in English and French (written and spoken)
  • Strong understanding of global and local regulatory requirements
  • Experience managing pharmacovigilance systems and processes
  • Proficiency in literature review and data management

Responsibilities

  • Coordinate and organize safety oversight activities at the national level
  • Execute routine pharmacovigilance tasks as Deputy LPV
  • Manage pharmacovigilance cases from various sources
  • Conduct literature reviews and integrate findings into safety reports
  • Ensure adherence to safety reporting processes for studies and programs
  • Manage periodic safety reporting and compliance tracking
  • Supervise risk management planning and local safety signal detection

Benefits

  • Remote work flexibility within Canada
  • Comprehensive training and development opportunities
  • Access to a supportive team environment
  • Opportunities for professional growth within a global organization
  • Participation in a robust quality assurance program
Full Job Description
French Version

** Pour être éligible à ce poste, vous devez résider dans le même pays/la même région commerciale où se trouve l'emploi **

Location: Canada, Télétravail

Mission

Elle est principalement responsable de:

  • La Responsable PV s'assure que la collecte, la déclaration et la gestion des informations de sécurité liées aux produits the clients sont organisées et réalisées conformément aux exigences mondiales de the clients ainsi qu'aux exigences réglementaires locales.
  • En tant que suppléant LPV, elle assiste le LPV dans le maintien de la supervision de la gestion des risques de sécurité et de toutes les autres activités de pharmacovigilance, et veille à la conformité en matière de pharmacovigilance ainsi qu'à l'état de préparation aux inspections pour l'ensemble des fonctions de l'affilié.


Activités et responsabilités
  • Mise en place du système de pharmacovigilance local:
  • Coordonner et organiser, au niveau national et en liaison avec le Global Safety (GS), toutes les activités liées à la supervision du profil de sécurité du portefeuille.
  • Responsable locale de la pharmacovigilance / Suppléant LPV:
  • La Responsable locale de la pharmacovigilance / Suppléant LPV est chargé d'exécuter les activités de pharmacovigilance courantes, ainsi que d'assurer la fonction de personne désignée en l'absence du LPV.
  • Gestion des cas de pharmacovigilance (PV), quelle que soit la source, conformément aux procédures internes.
  • Mise à jour du PSMF (le cas échéant), conformément aux exigences réglementaires locales.
  • Surveillance de la littérature:
  • Assurer l'examen de la littérature dans les journaux locales et traiter les cas identifiés dans les rapports de sécurité cliniques individuels (ICSR) conformément à la procédure interne.
  • Gestion des interfaces clés:
  • Assurer la supervision et la réconciliation périodique des interfaces pouvant constituer une source potentielle de cas de pharmacovigilance (PV).
  • Supervision des études et programmes:
  • Veiller à ce que des processus appropriés de déclaration de sécurité soient en place au niveau de l'affilié et, le cas échéant, décrits dans les documents locaux pertinents, pour les études interventionnelles et non interventionnelles mondiales et locales ainsi que pour les Programmes d'Usage Compassionnel, conformément aux processus globaux et aux exigences de l'autorité réglementaire locale.
  • Gestion des rapports périodiques:
  • Fournir les informations relatives à la sécurité aux équipes globales pour la préparation des rapports périodiques, si nécessaire.
  • Assurer la mise à jour du tableau de suivi des rapports périodiques avec preuves de soumission et indicateurs de conformité.
  • Garantir la soumission des rapports périodiques (le cas échéant) aux autorités réglementaires locales conformément aux processus globaux et aux exigences des autorités locales.
  • Supervision du Plan de Gestion des Risques (PGR) et de la mise en œuvre des mesures additionnelles de minimisation des risques (RMM):
  • Assurer la supervision de la mise en œuvre du PGR en collaboration avec les équipes concernées, conformément aux directives du Global Safety (GS) et aux exigences des autorités réglementaires locales.
  • Assurer le suivi de la distribution locale des RMM additionnelles ainsi que de leurs indicateurs de conformité.
  • Détection des signaux:
  • Assurer les activités locales de détection des signaux et informer le Global Safety de tout signal local potentiel identifié au cours des activités routinières de pharmacovigilance.
  • Assurer la supervision du rapport d'évaluation des signaux publié sur le portail WRA par le Global Safety.
  • Communication sur la sécurité et réponses aux demandes des Autorités Compétentes Nationales:
  • Garantir le traitement des demandes relatives à la sécurité, des autres problèmes de sécurité significatifs et, le cas échéant, de la gestion de crise locale/globale, conformément aux processus globaux et aux exigences de l'autorité réglementaire locale.
  • Maintenir la supervision de toute communication de sécurité adressée aux professionnels de santé ou aux consommateurs, le cas échéant.
  • Fournir au bureau du QPPV-EEE toutes les informations pertinentes afin de permettre leur supervision et le suivi des demandes provenant du bureau du QPPV-EEE, le cas échéant.
  • Se tenir informée des réglementations locales.
  • Étiquetage et engagements:
  • Garantir la prise en compte et contribuer (le cas échéant) aux mises à jour locales de l'étiquetage de sécurité en collaboration avec les Affaires Réglementaires locales.
  • Contribuer à la mise en œuvre des engagements, le cas échéant.


  • Système Qualité de Pharmacovigilance:
  • Assurer la mise en place et le maintien d'un système qualité local de pharmacovigilance conformément aux processus globaux et aux exigences des autorités réglementaires locales.
  • Assumer la responsabilité de la formation et de la sensibilisation du personnel concerné de l'affilié ainsi que, le cas échéant, des partenaires commerciaux ou prestataires de services, et maintenir les indicateurs de conformité aux formations locales.
  • Conventions locales de Pharmacovigilance:
  • Participer à l'initiation, la négociation, la rédaction, l'application et la mise à jour des conventions locales de pharmacovigilance avec les partenaires locaux ou prestataires de services.
  • Informer préalablement l'Unité Internationale de Global Safety de tout contrat mis en place localement concernant des activités de pharmacovigilance et/ou ayant un impact sur les activités de pharmacovigilance (tout contrat avec une société partenaire pour la sous-traitance d'activités spécifiques de pharmacovigilance).
  • Garantir la conformité aux conventions.
  • Fournir en temps utile, des commentaires à l'Unité Internationale de Global Safety sur toute modification dont le LPV a connaissance (par exemple : modification des produits concernés par la convention de pharmacovigilance).
  • Continuité des activités:
  • Assurer la continuité des activités de pharmacovigilance au niveau local, y compris la mise en place d'un système de couverture en dehors des heures ouvrables.
  • Veille réglementaire:
  • Assurer une surveillance continue des mises à jour de la législation locale, réaliser l'analyse d'impact et informer le Global Safety de tout changement.
  • Archivage:
  • Garantir l'archivage des documents de pharmacovigilance conformément aux exigences réglementaires locales et aux règles de protection des données, le cas échéant.
  • Audits et inspections:
  • Informer le Global Safety dès la réception d'une notification d'audit par un partenaire commercial ou d'une inspection, et assurer le rôle de point de contact local.
  • Assurer la mise en œuvre du plan CAPA dans les délais définis.
  • Gestion de l'unité locale de pharmacovigilance (personnel et activités), le cas échéant:
  • Superviser l'équipe locale de pharmacovigilance et promouvoir les standards de pharmacovigilance au sein de l'organisation.
  • Veiller à ce que les activités de pharmacovigilance disposent des ressources nécessaires.


English Version

**To be eligible for this position, you must reside in the same country/sales region where the job is located. **

Location: Canada, Home-Based

Mission

The Candidate is primarily responsible for:
  • The PV (Pharmacovigilance) Manager ensures that the collection, reporting, and management of safety information related to the clients products are organized and conducted in compliance with the clients global requirements and local regulatory requirements.
  • As the Deputy Local Pharmacovigilance Officer (LPV), she supports the LPV in maintaining oversight of safety risk management and all other pharmacovigilance activities, ensuring pharmacovigilance compliance and inspection readiness across all affiliate functions.
Activities and Responsibilities
Establishment of the Local Pharmacovigilance System
  • Coordinate and organize, at the national level and in collaboration with Global Safety (GS), all activities related to oversight of the safety profile of the product portfolio.
Local Pharmacovigilance Officer / Deputy LPV
  • Carry out routine pharmacovigilance activities and serve as the designated responsible person in the absence of the LPV.
  • Manage pharmacovigilance (PV) cases from all sources in accordance with internal procedures.
  • Update the Pharmacovigilance System Master File (PSMF), where applicable, in accordance with local regulatory requirements.
Literature Monitoring
  • Conduct reviews of local medical literature and process identified cases into Individual Case Safety Reports (ICSRs) in accordance with internal procedures.
Management of Key Interfaces
  • Ensure oversight and periodic reconciliation of interfaces that may represent potential sources of pharmacovigilance cases.
Oversight of Studies and Programs
  • Ensure that appropriate safety reporting processes are in place at the affiliate level and, where applicable, documented in relevant local procedures for global and local interventional and non-interventional studies, as well as Compassionate Use Programs, in compliance with global processes and local regulatory requirements.
Periodic Report Management
  • Provide safety information to global teams for the preparation of periodic reports, when required.
  • Maintain the periodic reporting tracking system, including evidence of submissions and compliance indicators.
  • Ensure submission of periodic reports, where applicable, to local regulatory authorities in accordance with global processes and local authority requirements.
Oversight of Risk Management Plans (RMPs) and Additional Risk Minimization Measures (RMMs)
  • Oversee implementation of Risk Management Plans (RMPs) in collaboration with relevant teams, in accordance with Global Safety guidance and local regulatory requirements.
  • Monitor local distribution of additional Risk Minimization Measures (RMMs) and related compliance metrics.
Signal Detection
  • Conduct local signal detection activities and notify Global Safety of any potential local safety signals identified during routine pharmacovigilance activities.
  • Oversee review of signal assessment reports published by Global Safety on the WRA portal.
Safety Communications and Responses to Requests from National Competent Authorities
  • Ensure management of safety-related inquiries, significant safety issues, and, where applicable, local/global crisis management in compliance with global processes and local regulatory requirements.
  • Maintain oversight of safety communications directed to healthcare professionals or consumers, where applicable.
  • Provide the EU QPPV Office (Qualified Person Responsible for Pharmacovigilance) with all relevant information necessary for oversight and follow-up of requests, where applicable.
  • Remain informed of local regulatory requirements.
Labeling and Commitments
  • Ensure consideration of and contribute, where applicable, to local safety labeling updates in collaboration with local Regulatory Affairs.
  • Contribute to the implementation of regulatory commitments when applicable.
Pharmacovigilance Quality System
  • Establish and maintain a local pharmacovigilance quality system in accordance with global processes and local regulatory authority requirements.
  • Be responsible for training and awareness of relevant affiliate personnel and, where applicable, business partners or service providers, while maintaining compliance metrics for local training requirements.
Local Pharmacovigilance Agreements
  • Participate in the initiation, negotiation, drafting, implementation, and updating of local pharmacovigilance agreements with local partners or service providers.
  • Inform the Global Safety International Unit in advance of any locally established contract involving pharmacovigilance activities and/or impacting pharmacovigilance activities (including outsourcing arrangements with partner companies).
  • Ensure compliance with these agreements.
  • Provide timely feedback to the Global Safety International Unit regarding any changes known to the LPV (for example, changes to products covered under a pharmacovigilance agreement).
Business Continuity
  • Ensure continuity of local pharmacovigilance activities, including establishing an out-of-hours coverage system.
Regulatory Intelligence
  • Continuously monitor changes in local legislation, conduct impact assessments, and inform Global Safety of any relevant changes.
Archiving
  • Ensure pharmacovigilance documents are archived in compliance with local regulatory requirements and applicable data protection regulations.
Audits and Inspections
  • Notify Global Safety immediately upon receipt of an audit notification from a business partner or an inspection notice, and serve as the local point of contact.
  • Ensure implementation of CAPA (Corrective and Preventive Action) plans within established timelines.
Management of the Local Pharmacovigilance Unit (Staff and Activities), Where Applicable
  • Supervise the local pharmacovigilance team and promote pharmacovigila

About IQVIA

Innovex offers superior and creative advice to corporations. In addition, they raised venture capital for our own affiliate companies, in addition to having assisted clients in fund-raising efforts, new venture outreaches, and financing. Their engineers and technical staff offer varied backgrounds in manufacturing, high tech, product design, quality control, safety, biomechanics, and robotics.

IQVIA Careers

Join the vibrant team at IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services to the healthcare industry. IQVIA is recognized for its commitment to innovation, leadership in healthcare, and a culture that celebrates diversity and inclusion.

Work You’ll Do

At IQVIA, we offer job opportunities that empower you to leverage your skills and drive healthcare forward. Become part of a team that thrives on innovation and the pursuit of operational excellence, helping to improve patient outcomes across the globe.

Transform Your Career

IQVIA is the place where you can transform the world of healthcare while advancing your career. With a variety of positions available, from research and development to business analytics, IQVIA is at the forefront of the industry. Our leadership is committed to fostering a culture of growth and professional development, making IQVIA a prime environment for both seasoned professionals and those seeking an internship to kickstart their career.

Innovative Work Environment

Join over 50,000 dedicated professionals in a dynamic environment where technology meets healthcare. At IQVIA, innovation isn’t just a buzzword; it's the backbone of how we solve complex challenges. With cutting-edge resources and a collaborative global team, your work at IQVIA directly contributes to advancements in life sciences.

Career Development and Benefits

IQVIA believes in nurturing its team members not just as employees but as individuals seeking to grow their careers. We support this with unmatched benefits, diversity training, and opportunities for leadership development. Our commitment to your career growth is matched by our dedication to providing a supportive and inclusive workplace.

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Whether you’re looking for a full-time position, part-time work, or a graduate internship, IQVIA offers a range of employment options to match your career ambitions. Our hiring process is designed to be transparent and engaging, helping you to understand where your skills can best be utilized within the company.

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Learn more about IQVIA
Size
82,000 employees
Market Cap
$37.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$279 million
Founded
2016
5 Year Trend
+15.3%
Revenue
$11.3 billion
NASDAQ
IQV
* Ladders Estimates

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