Assoc Mgr, Safety Operations (with Portuguese Advanced) at IQVIA

Buenos Aires, Buenos Aires, Argentina

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Bachelor's degree in Life Sciences
Minimum 5 years of relevant experience
Minimum 3 years of specific Pharmacovigilance experience (intake, case processing, regulatory submissions)
Strong understanding of global and local pharmacovigilance regulations and guidelines
Excellent written and verbal communication skills
Proficiency in English, C1/2 (mandatory). Will be evaluated
Proficiency in Portuguese, C1/2 (mandatory). Will be evaluated
Strong organizational and time management skills
Ability to work independently and as part of a team
Proficiency in using electronic data management systems (e.g., Argus, Apex)
Preferred Qualifications
Experience working with global safety databases
Experience as people manager with direct reports
1 year experience of Adverse Events Case Triage, Processing and Submission

Responsibilities

Oversight of Pharmacovigilance Operations: Monitor and oversee all safety-related operations and communication activities
Serve as the primary point of contact for the Sponsor (when applicable)
Ensure efficient and accurate ICSR (Individual Case Safety Report) surveillance, including collection, reporting, and follow-up
Manage translation processes as needed
Author local case narratives for regulatory reporting as required by local authorities
Support local literature searches, reconciliations, and quality assurance activities
Assist with audit and inspection readiness
Collaborate effectively with internal and external stakeholders
Mailbox Screening: Monitor multiple regional/global AE email inboxes in various languages for all Customer Affiliates
Assess and take action on all received emails
Case Intake: Create Case Reports into the Global Safety Database
Follow-up Correspondence: Perform follow-up with ICSR reporters to obtain additional information as per SOPs
Reconciliation: Conduct reconciliations with internal functions and licensing partners
Compliance Investigations: Perform compliance investigations for specific cases

Skills

Pharmacovigilance

ICSR Processing

Case Intake

Regulatory Reporting

Literature Searching

Reconciliations

Quality Assurance

Audit Readiness

Compliance Investigations

Global Safety Database

English Proficiency

Portuguese Proficiency

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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