Operation Specialist 2
Job Overview
The Operations Specialist 2 - Home Based, is responsible for end‑to‑end processing and oversight of Safety data, applying in‑depth pharmacovigilance expertise and complex decision‑making. This role acts as a subject matter specialist, supports clinical trial and post‑marketing activities, leads or supports small to medium operational projects, and mentors junior team members while ensuring compliance, quality, and timely delivery.
Key Responsibilities
Perform full‑service processing of Safety cases (including SAEs) according to regulations, SOPs, and project requirements.
Collect, track, assess, and process Adverse Events (AEs) using safety databases, including data entry, coding, narrative writing, and case closure.
Assess seriousness, reportability, causality, listedness, and expectedness; support medical review activities when required.
Generate, track, and submit regulatory reports to health authorities and stakeholders within defined timelines.
Support reconciliation activities, literature screening, quality reviews, and adjudication processes.
Coordinate translations and liaise with clinical teams, investigators, clients, and internal functional groups.
Ensure compliance with project protocols, regulatory requirements, and training obligations.
Monitor project metrics, productivity, and quality indicators; provide feedback to management.
Mentor and train junior team members; contribute to training initiatives and process improvements.
Support Safety Publishing, Risk Management, Safety Surveillance, and Medical Information activities as applicable.
Participate in audits, inspections, working groups, and continuous improvement initiatives.
Requirements
Bachelor’s degree in Life Sciences, Healthcare, or related field.
At least 3 years of Pharmacovigilance experience, preferably including clinical trials and some post‑marketing exposure.
Job Countries: Brazil and Mexico.
Strong experience with Safety databases (e.g., Argus Safety), including full data entry and narrative writing.
Solid knowledge of global, regional, and local pharmacovigilance regulations and guidelines.
Excellent attention to detail, organizational skills, and ability to manage multiple priorities under tight timelines.
Strong communication skills (written and verbal) and ability to interact with cross‑functional teams and clients.
Proven ability to work independently, take ownership, and collaborate effectively in a team environment.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Apply To This Job
The Operations Specialist 2 - Home Based, is responsible for end‑to‑end processing and oversight of Safety data, applying in‑depth pharmacovigilance expertise and complex decision‑making. This role acts as a subject matter specialist, supports clinical trial and post‑marketing activities, leads or supports small to medium operational projects, and mentors junior team members while ensuring compliance, quality, and timely delivery.
Key Responsibilities
Perform full‑service processing of Safety cases (including SAEs) according to regulations, SOPs, and project requirements.
Collect, track, assess, and process Adverse Events (AEs) using safety databases, including data entry, coding, narrative writing, and case closure.
Assess seriousness, reportability, causality, listedness, and expectedness; support medical review activities when required.
Generate, track, and submit regulatory reports to health authorities and stakeholders within defined timelines.
Support reconciliation activities, literature screening, quality reviews, and adjudication processes.
Coordinate translations and liaise with clinical teams, investigators, clients, and internal functional groups.
Ensure compliance with project protocols, regulatory requirements, and training obligations.
Monitor project metrics, productivity, and quality indicators; provide feedback to management.
Mentor and train junior team members; contribute to training initiatives and process improvements.
Support Safety Publishing, Risk Management, Safety Surveillance, and Medical Information activities as applicable.
Participate in audits, inspections, working groups, and continuous improvement initiatives.
Requirements
Bachelor’s degree in Life Sciences, Healthcare, or related field.
At least 3 years of Pharmacovigilance experience, preferably including clinical trials and some post‑marketing exposure.
Job Countries: Brazil and Mexico.
Strong experience with Safety databases (e.g., Argus Safety), including full data entry and narrative writing.
Solid knowledge of global, regional, and local pharmacovigilance regulations and guidelines.
Excellent attention to detail, organizational skills, and ability to manage multiple priorities under tight timelines.
Strong communication skills (written and verbal) and ability to interact with cross‑functional teams and clients.
Proven ability to work independently, take ownership, and collaborate effectively in a team environment.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Apply To This Job