Drug Safety Physician

Role & Responsibilities

Prepare aggregate safety reports including PBRERs, PSURs, Addendum PSURs, ACOs, PADERs and PSUR line listings

Perform quality checks of aggregate safety reports in line with client conventions and regulatory requirements

Conduct signal detection activities including cumulative analyses, issue-based event analyses, SERs and Drug Safety Reports

Review published literature and case listings for safety surveillance

Maintain vigilance over important and designated medical events

Interact with client teams to discuss potential safety signals and emerging issues

Support preparation and maintenance of Risk Management Plans (RMPs)

Perform follow-up with clients to obtain incomplete or missing safety information

Perform medical review of Individual Case Safety Reports (ICSRs)

Perform medical review of narratives for Clinical Study Reports (CSRs)

Provide medical guidance to drug safety scientists on ICSR and CSR narrative processing

Maintain up-to-date knowledge of product safety profiles, labeling documents and SOPs

Ensure compliance with global regulatory reporting timelines and requirements

Maintain accurate safety records in compliance with guidelines and SOPs

Qualification

MBBS or MD (preferably in a clinical branch)

Experience

Pharmacovigilance / drug safety experience preferred

Skills

Strong ability to prepare concise and accurate medical synopses and narratives

Ability to evaluate and interpret safety data independently

Excellent written and spoken English communication skills

Proficiency in MS Word, Excel, PowerPoint and web-based safety applications

Strong typing, transcription accuracy and attention to detail

About the Company

Continuum is a leading contract research organization providing services in Pharmacovigilance, Regulatory, Evidence Evaluation and Technology

The organization employs scientists and physicians to support global safety and regulatory operations