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Iqvia Biotech
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Senior Medical Safety Advisor

Senior Medical Safety Advisor

Iqvia Biotech

2 - 5 years

6 - 10 Lacs

bengaluru

Posted:2 days ago| Platform:

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Skills Required

standard operating procedures medical monitoring medicine pharmacovigilance literature review clinical data drug healthcare excel gcp case processing clinical research safety writing life sciences surveillance powerpoint communication skills

Work Mode

Work from Office

Job Type

Full Time

Job Description

IQVIA Biotech is looking for Senior Medical Safety Advisor to join our team

Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs).
Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases.
Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications, or other medical data listings.
Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported.
Lead and participate in initiatives to ensure service delivery from productivity, compliance, and quality perspectives within regulatory/contracted timelines.
Ensure update of watch list, list of expectedness, labeling list/RSIs, etc., for assigned products and develop such capabilities within the team.
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 Qualified Persons for Pharmacovigilance projects, as applicable.
Maintain awareness of medical safety-regulatory industry developments and provide support and participate in signal detection efforts, e.g., strategy meetings, etc., as applicable.

Job Requirements

A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education is required.
Three (3) years of experience practicing clinical medicine after award of medical degree is necessary.
Sound knowledge of Medicine and In-depth knowledge of applicable global, regional, and local clinical research regulatory requirements (GCP and ICH guidelines) are essential.
Knowledge of Pharmacovigilance, ICSR, and Aggregate reports is needed, along with proficiency in departmental standard operating procedures (SOPs).
Skill in using multiple safety databases and adequate computer skills, especially Microsoft Word, Excel, and PowerPoint, are expected.
Good communication skills, both verbal and written, are crucial, along with the ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients, and regulatory agency representatives.
A valid medical license or equivalent from the country or region in which the individual resides and works is preferred.

Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

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