Senior Drug Safety Physician

2+ years

Not Disclosed

Remote

10 Sept. 27, 2024

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

At Parexel, when our values align, there’s no limit to what we can achieve.

We are united by a common goal: to improve global health. From clinical trials to regulatory consulting and market access, every solution we provide is grounded in a profound commitment to our mission.

Each of us, regardless of our role at Parexel, contributes to the development of therapies that ultimately benefit patients. We approach our work with empathy, taking it personally and striving to make a meaningful impact.

Position: Senior Drug Safety Physician

As a Senior Drug Safety Physician, you will be responsible for medical safety monitoring and pharmacovigilance activities for assigned projects. Your role will include providing medical review, analysis, and guidance on all required safety reports, and serving as a Subject Matter Expert (SME) in support of presales activities and audits.

Key Responsibilities:

Maintain a thorough understanding of the adverse event/safety profile of assigned products, including labeling documents, data handling conventions, and client guidelines.
Stay informed about global regulatory requirements and reporting obligations, ensuring compliance with internal and regulatory timelines for adverse event reporting.
Communicate and address issues related to the review process with your Line Manager, Project Leader, or designated representatives.
Collaborate with internal and external stakeholders to resolve issues effectively.
Attend and present at client and cross-functional meetings as an SME.
Assist Project Leads and Functional Leads during audits and inspections.
Provide input for process improvements to enhance operational efficiency.
Work closely with Project Leads and Functional Leads to meet all Key Performance Indicators (KPIs) for the processes.
Act as a pharmacovigilance representative and safety scientist.
Support Bid defense meetings.
Mentor junior Drug Safety Physicians.

Join us at Parexel, where your expertise and commitment can make a difference in the lives of patients worldwide.

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Senior Drug Safety Physician

Job Description

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