Senior Medical Safety Advisor at IQVIA

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, Clinical ResearchIndustries

Requirements

(None specified)

Responsibilities

Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs), including narrative content, queries, coding, expectedness, seriousness, and causality
Compose, edit, and medically review Analysis of Similar Events (AOSEs) for expedited cases, adhering to 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 supported projects
Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) to ensure appropriate safety content and data capture
Provide aggregate reviews of safety information, including clinical data, post-marketing data, literature reviews, and observational studies, to maintain oversight of a product’s safety profile (e.g., DSUR, RMP, PBRER, ad hoc regulatory reports)
Ensure service delivery from a productivity, compliance, and quality perspective within regulatory/contracted timelines. Lead and participate in initiatives for the same from a team delivery perspective
Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment
Ensure update of watch lists, lists of expectedness, labeling lists/RSIs, etc., for assigned products and develop such additional capabilities within the team
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, as applicable
Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable
Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable
Provide medical escalation support for medical information and EU Q

Skills

Key technologies and capabilities for this role

PharmacovigilanceAdverse Event ReviewSerious Adverse EventsAdverse Drug ReactionsAnalysis of Similar EventsMedical CodingCausality AssessmentDSURPBRERRMPProtocol ReviewCRF ReviewAggregate Safety Reports

Questions & Answers

Common questions about this position

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

This information is not specified in the job description.

What are the key responsibilities of the Senior Medical Safety Advisor?

Key responsibilities include performing medical review of adverse events and drug reactions, composing and reviewing Analysis of Similar Events, providing aggregate safety reviews, serving as an internal consultant, and leading training and audit support activities.

What skills or expertise are required for this role?

The role requires medical expertise in pharmacovigilance, experience in evaluating safety data including adverse events, seriousness, causality, and expectedness, proficiency in aggregate safety reporting (e.g., DSUR, PBRER), and leadership skills in guiding teams and therapeutic area guidance.

What is the employment type for this position?

This is a full-time position.

What makes a strong candidate for the Senior Medical Safety Advisor role?

A strong candidate will have extensive medical expertise in pharmacovigilance, experience leading safety teams, proficiency in medical review of AEs/ADRs, aggregate reporting, and regulatory compliance, along with skills in training, consulting, and project leadership.

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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