Manager, Safety Operations at IQVIA

Hefei, China

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Life SciencesIndustries

Requirements

Knowledge and expertise in complex decision-making activities
Ability to review, assess, and process safety data and information
Understanding of applicable regulations, guidelines, and Standard Operating Procedures (SOPs)
Experience with Pharmacovigilance activities, including collecting and tracking Adverse Events (AE)/endpoint information
Experience with Pharmacovigilance activities, including determining initial/update status of incoming events
Experience with Pharmacovigilance activities, including database entry
Experience with Pharmacovigilance activities, including coding AE and Products
Experience with Pharmacovigilance activities, including writing narratives
Experience with Pharmacovigilance activities, including literature related activities
Experience with Pharmacovigilance activities, including quality review
Experience with Pharmacovigilance activities, including assisting with reconciliation and case closure
Experience with Pharmacovigilance activities, including coordinating translations
Ability to assess safety data for reportability to relevant authorities
Experience with adjudication activities
Understanding of Safety Publishing, Risk Management, Safety Surveillance, and Medical Information
Ability to meet quality, productivity, and delivery standards
Compliance with project-related processes and activities
Strong communication and interpersonal skills
Ability to build a positive team environment and provide training and mentoring

Responsibilities

Process safety data according to regulations, guidelines, SOPs, and project requirements
Perform Pharmacovigilance activities as per project requirements
Determine initial/update status of incoming events and enter data into databases
Code AE and Products, write narratives, and conduct literature reviews
Assess safety data for reportability to regulatory authorities
Track and reportable cases to relevant authorities, ethics committees, and investigators
Liaise with stakeholders to facilitate expedited reporting
Coordinate translations
Contribute knowledge and expertise to assigned deliverables
Ensure compliance to all project-related processes and activities
Provide training and mentoring to junior team members
Provide oversight and understanding of operational team status and metrics
Maintain project files, templates, and databases
Establish and maintain effective team and project communications
Provide feedback on project performance to junior team members

Skills

Pharmacovigilance

Adverse Event Processing

Safety Data Review

Medical Coding

Narrative Writing

Database Entry

Literature Review

Quality Review

Reconciliation

Regulatory Reporting

Risk Management

Safety Surveillance

SOP Compliance

Mentoring

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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