Global Pharmacovigilance Specialist

Há 1 mês


Lisboa, Lisboa, Portugal Organon Tempo inteiro

Job Summary

We are seeking a highly skilled Global Pharmacovigilance Specialist to join our team at Organon. As a key member of our Pharmacovigilance department, you will be responsible for the day-to-day management of adverse events case management, including case intake and follow-up activities in accordance with Global Pharmacovigilance procedures and country regulations.

Key Responsibilities

  • Responsible for the intake of cases received from designated points of contact, vendors, and business partners for Individual Case Safety Reports (ICSRs), including tracking and translation to English and forwarding of information to the Data Management Center.
  • Performing ICSR acknowledgments and reconciliation activities.
  • Execution of local PV processes and activities in alignment with PV systems and their associated Quality Management System, following department SOPs, company Policies and Procedures, and country legislation.
  • Reconciliation activities for PV cases received from local operating units and contractual partners, and processing reports in accordance with local procedures/PV legislations.
  • Supports Patient Support Programs and/or Market Research vendor-related activities, as applicable.
  • Files, stores, and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.
  • Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately, assisting in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues.
  • Supports local PV audits and inspections, including readiness activities, and supports other audits/inspections, including the development of CAPAs in response to findings/observations.
  • Participates in and supports audits of contractual partners/vendors as necessary, may be trained and assigned responsibility to conduct qualification and ongoing audits of vendors and perform due diligence activities for local country licensing agreements.
  • Assists in developing local procedures for the department, to ensure quality PV data, and evaluates processes for potential improvement in efficiency and effectiveness.
  • Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
  • Supports training of local company staff, distributors, vendors, business partners, including training documentation.
  • May be assigned responsible for ensuring PV language is included in local agreements and ensuring maintenance of BDLM with respect to local and regional contracts.
  • May be assigned responsibility for ensuring appropriate implementation and oversight of local Risk Minimization Measures and ARMMs.
  • Liaises with local business units to keep them apprised of safety activities and provide input on strategic decisions, with Management oversight.

Requirements

  • Minimum of 1 year of industry experience in pharmacovigilance and/or regulatory affairs.
  • General knowledge of PV regulations within the assigned country and be an expert in PV processes/activities.
  • Good communication and time management skills.
  • Health, life science, or medical science degree or equivalent by education/experience.
  • Fluent in English (written and spoken) while proficient in local language.


  • Lisboa, Lisboa, Portugal Organon Tempo inteiro

    **Job Summary**Organon is seeking a highly skilled Drug Safety Specialist to join our team. As a key member of our Pharmacovigilance team, you will be responsible for managing adverse event cases, ensuring compliance with global and local regulations, and providing support for patient safety initiatives.**Key Responsibilities**Manage day-to-day adverse event...

  • Pharmacovigilance Specialist

    4 semanas atrás


    Lisboa, Lisboa, Portugal Organón Tempo inteiro

    Job DescriptionJob Title: Pharmacovigilance SpecialistJob Summary:We are seeking a highly skilled Pharmacovigilance Specialist to join our team at Organon. As a key member of our Pharmacovigilance department, you will be responsible for ensuring the safe and effective use of our products.Responsibilities:Manage adverse event cases from receipt to closure in...


  • Lisboa, Lisboa, Portugal Organon Tempo inteiro

    Job SummaryAs a Global Pharmacovigilance Specialist at Organon, you will play a critical role in ensuring the safety of our products. Your primary responsibility will be to manage adverse event cases, including case intake and follow-up activities, in accordance with Global Pharmacovigilance procedures and country regulations.Key ResponsibilitiesIntake and...


  • Lisboa, Lisboa, Portugal Primevigilance Tempo inteiro

    Established in 2008, PrimeVigilance has grown organically year after year to become a leading provider of pharmacovigilance services. As a global company with staff across Europe, North America, and Asia, we cover a range of services including Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.We value our relationships with...

  • Pharmacovigilance Specialist

    4 semanas atrás


    Lisboa, Lisboa, Portugal Organon Tempo inteiro

    Job SummaryWe are seeking a highly skilled Pharmacovigilance Specialist to join our team. The ideal candidate will have a strong background in pharmacovigilance and regulatory affairs, with a minimum of 1 year of industry experience.Key ResponsibilitiesManage day-to-day adverse events case intake and follow-up activities in accordance with Global...


  • Lisboa, Lisboa, Portugal PrimeVigilance Tempo inteiro

    Job Overview: PrimeVigilance is seeking a highly skilled Clinical Pharmacovigilance Specialist to join our team in global operations.About the Role: As a key member of our PV team, you will be responsible for reviewing and approving post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials. You...


  • Lisboa, Lisboa, Portugal Prime Vigilance Ltd Tempo inteiro

    Job DescriptionThe position of Pharmacovigilance Associate is a key role in our team at PrimeVigilance. As a Pharmacovigilance Associate, you will be responsible for the creation, maintenance, and review of client Pharmacovigilance System Master Files, in line with global regulations and PrimeVigilance requirements.Key ResponsibilitiesAuthoring, revision,...


  • Lisboa, Lisboa, Portugal Primevigilance Tempo inteiro

    At PrimeVigilance, we are committed to providing exceptional support to our clients in the pharmaceutical and biotechnology industries.**Job Summary**We are seeking a highly skilled Pharmacovigilance System Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for creating, maintaining, and reviewing...

  • Pharmacovigilance Specialist

    4 semanas atrás


    Lisboa, Lisboa, Portugal Organón Tempo inteiro

    Job DescriptionOrganón is seeking a highly skilled Pharmacovigilance Specialist to join our team. The ideal candidate will have a strong background in pharmacovigilance and regulatory affairs.Responsibilities:Manage day-to-day adverse events case management, including case intake and follow-up activities in accordance with Global Pharmacovigilance...

  • Pharmacovigilance Specialist

    3 semanas atrás


    Lisboa, Lisboa, Portugal Organon Tempo inteiro

    Job DescriptionWe are seeking a highly skilled Pharmacovigilance Specialist to join our team at Organon. The ideal candidate will have a strong background in pharmacovigilance and regulatory affairs, with excellent communication and time management skills.ResponsibilitiesManage day-to-day adverse events case management, including case intake and follow-up...


  • Lisboa, Lisboa, Portugal Prime Vigilance Ltd Tempo inteiro

    Company OverviewPrime Vigilance Ltd is a specialized pharmacovigilance service provider established in 2008. With organic growth year after year, the company has achieved global recognition for its services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. Job DescriptionThe Clinical Pharmacovigilance Specialist will be...


  • Lisboa, Lisboa, Portugal Organon Tempo inteiro

    About OrganonOrganon is a global healthcare company dedicated to delivering innovative health solutions that empower people to live their best lives. We focus on women's health, biosimilars, and diverse health solutions.Salary InformationThe estimated annual salary for this position is between $65,000 and $90,000, depending on the location and qualifications...


  • Lisboa, Lisboa, Portugal Primevigilance Tempo inteiro

    About the Company">We are PrimeVigilance, a leading pharmacovigilance service provider with global reach and expertise. Our team of professionals is dedicated to delivering high-quality support to pharmaceutical and biotechnology partners across various therapy areas.At PrimeVigilance, we prioritize diversity, equity, and inclusion by creating an equal...


  • Lisboa, Lisboa, Portugal Phiture Tempo inteiro

    About UsAt Sandoz, we strive to make a meaningful difference in the lives of millions of patients worldwide. Our commitment to innovation and quality has made us a leader in the global medicines industry.We are proud to have touched the lives of almost 500 million patients last year and we're eager to continue our mission of providing low-cost, high-quality...


  • Lisboa, Lisboa, Portugal PrimeVigilance Tempo inteiro

    Pharmacovigilance Expert OpportunityWe are seeking a highly skilled Pharmacovigilance Expert to join our team at PrimeVigilance.About the Role:As a Pharmacovigilance Expert, you will be responsible for participating in signal detection activities, reviewing line listings, and drafting complex reports.You will work closely with our project teams to ensure...


  • Lisboa, Lisboa, Portugal Organón Tempo inteiro

    About OrganónAt Organón, we are committed to providing innovative healthcare solutions that make a meaningful difference in people's lives.Job Title: Senior Pharmacovigilance SpecialistJob Type: Full-timeLocation: Remote (Flexible)Job Description:Key Responsibilities:Responsible for day-to-day adverse events case management, including case intake and...

  • Patient Safety Specialist

    2 semanas atrás


    Lisboa, Lisboa, Portugal Sandoz Tempo inteiro

    About SandozSandoz is a leading global generic and biosimilar medicines company, with a mission to pioneer access for patients. With a presence in almost 140 countries, our products touch the lives of nearly 500 million patients every year.We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients...

  • Pharmacovigilance Specialist

    2 semanas atrás


    Lisboa, Lisboa, Portugal Prime Vigilance Ltd Tempo inteiro

    We are PrimeVigilance, a leading provider of pharmacovigilance services. As a Benefit Risk Officer, you will be part of our project team, performing and supporting pharmacovigilance activities. Key Responsibilities:• Participate in signal detection activities, including set-up and review of line listings for signal detection reports.• Draft complex...


  • Lisboa, Lisboa, Portugal Healthcare Businesswomen'S Association Tempo inteiro

    About SandozSandoz, a leading generic and biosimilar medicines company, has the opportunity to shape the future of healthcare. Our innovative production sites, acquisitions, and partnerships enable us to provide low-cost, high-quality medicines sustainably.Why Work at Sandoz?At Sandoz, we value diversity and inclusion. Our agile and collegiate environment...


  • Lisboa, Lisboa, Portugal Primevigilance Tempo inteiro

    Company Overview:PrimeVigilance is a leading specialized mid-size pharmacovigilance service provider, established in 2008. The company has achieved global organic growth year after year, with staff based across Europe, North America, and Asia, covering services within Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.With a...