Pharmacovigilance Specialist Pvs

hace 5 meses

Buenos Aires, Argentina Caidya A tiempo completo

**Job Title: Pharmacovigilance Specialist PVS**

**Job Location**: Argentina (In or around the Buenos Aires area)

**Job Overview**:
The Pharmacovigilance Specialist (PVS) primary responsibility is SAE case management. This includes but is not limited to initial case disposition, confirmation of case disposition with Medical Monitor (MM)/Safety Physician PV (SP PV), MM, receipt of adverse event data, data entry, source document data extraction, draft narrative development, follow-up management and reporting according to regulatory requirements. All activities will be in accordance with Company and/or client SOPs, ICH Guidelines, and local regulatory requirements.

**Job Duties and Responsibilities**:

- Will be required to conduct in-person submissions to local authorities, which is in the Buenos Aires area.
- Good working knowledge of medical/drug coding process (MedDRA and WHO drug dictionary)
- Proficient in processing safety information of clinical trials, post-marketing surveillance, and medical devices
- Perform quality review for expedited cases prior to delivery to the client as needed.
- Ability to perform reconciliation of SAEs between the safety database and clinical database according to defined processes, if needed.
- Ability to prepare a Draft Safety Management Plan (SMP)
- Tracking and triage of case information for processing
- Prioritize incoming AE/SAE/ER information for further processing and confirm receipt, as required.
- Identify potential 7-Day and 15-Day Alerts
- Assumes case ownership responsibility for nonserious, spontaneous, and or serious clinical trial domestic and foreign cases as applicable.
- Consult with multiple stakeholders (e.g., the sponsor / medical monitor/pharmacovigilance physician) to decide on action and/or additional steps to provide complete narratives to the sponsor.
- Handling of safety information according to given processes and procedures by CPWW and/or client SOPs, WPs, and Guidelines
- Perform expedited reporting according to project requirements
- Possess general working knowledge of the PV regulatory framework
- Other similar administrative tasks will be required

**Supervisory Responsibilities**:

- No supervisory responsibilities

**Job Requirements**:
Education
- Degree in life science, nursing/pharmacy qualification, or other advanced or equivalent appropriate healthcare or pharmaceutical industry experience or education, e.g., laboratory experience.
- Medical Documentalist, Medical Documentation Assistant, or Nurse with extensive clinical experience or life science degree (e.g., a natural scientist with a degree in biology or pharmaceutical medicine of a similar specialty) preferred.

Experience
- At least 1-2 years’ experience in the tasks and responsibilities performed by a Junior PVS

Skills/Competencies
- General knowledge of drug therapy, disease states, clinical research
- Ability to maintain and protect client, patient, and corporate confidentiality.
Sound working knowledge of regulatory reporting requirements and international regulations (EU, US, Japan, and Asia)
- Ability to work in an environment of rapidly changing priorities and manage multiple client projects
- Ability to review medical data from clinical trials and post-marketing experiences, as applicable.
- Ability to organize and manage work to meet strict timelines
- Ability to provide exceptional customer service and professional interactions with a varied customer base, as necessary.
- Use of MS Office products to a competent standard - Word, Excel, PowerPoint
- Ability to work independently with high reliability and a high sense of responsibility
- Ability to work as a member of a team and possess confident communication skills, both written and verbal.
- Ability to communicate in English (both written and verbal)
- Willingness to provide guidance and training to less experienced staff
- Willingness for continuous on-the-job training and qualifications measures
- Ability to work with careful attention to details

Capabilities
- Able to conduct in-person submissions to local authorities, which is in the Buenos Aires area.
- Able to virtually attend meetings with client and/or other staff members
- Ability to work remotely or in the office

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