Senior Medical Safety Advisor (a 12-month fixed-term contract) at IQVIA

Budapest, Hungary

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

A Medical Degree and 3 years of experience practicing clinical medicine
At least 2 years of pharma experience
Knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Knowledge of Pharmacovigilance- ICSR and Aggregate reports
In-depth knowledge of departmental standard operating procedures (SOPs)
Skill in use of multiple safety databases
Ability to establish and maintain effective working relationships
A valid medical license

Responsibilities

Perform medical review and clarification of trial-related Adverse Events and post-marketing adverse drug reactions including narrative content, queries, coding, expectedness, seriousness, causality and company summary
Compose, edit and medically review Analyses of Similar Events for expedited cases as appropriate based on regulatory requirements
Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture
Provide aggregate reviews of safety information, including but not limited to clinical data, post-marketing, literature review and observational studies to maintain oversight of a product’s safety profile (e.g: DSUR, RMP, PBRER, ad hoc regulatory reports etc)
Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines
Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment
Ensure update of watch list, list of expectednesess, labeling list/RSIs etc for the assigned products
Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives
Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract
Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects
Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects
24 hour medical support as required on assigned projects

Skills

Key technologies and capabilities for this role

PharmacovigilanceAdverse EventsSAEsSADRsDSURRMPPBRERCausality AssessmentSeriousness AssessmentMedical CodingProtocol ReviewInvestigative BrochureCRF ReviewAggregate Reports

Questions & Answers

Common questions about this position

What qualifications are required for the Senior Medical Safety Advisor role?

Candidates need a Medical Degree and 3 years of experience practicing clinical medicine, plus at least 2 years of pharma experience and knowledge of global, regional, and local clinical research regulatory requirements including Good Clinical Practice (GCP).

Is this a remote position or does it require office work?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What are the main responsibilities of this position?

The role involves performing medical reviews of adverse events, composing analyses of similar events, providing coding reviews, serving as an internal consultant, and leading safety surveillance activities for assigned products.

What makes a strong candidate for this Senior Medical Safety Advisor position?

A strong candidate will have a Medical Degree with clinical practice experience, pharma industry background, and expertise in pharmacovigilance regulations like GCP, along with leadership skills for managing safety teams and projects.

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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