Clinician, Product Safety and Performance

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Job Function:

Product Safety

Job Sub Function:

Product Safety Risk Management MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Taguig, National Capital Region (Manila), Philippines

Job Description:

Position Summary

The Medical Safety Clinician assists and supports the medical and scientific functions within safety evaluations for assigned products. Such tasks include preparation and coordination of Post Market Surveillance plans and reports as well as reviews of aggregate safety data. The Medical Safety Clinician will also support Risk Management activities by serving as a coordinator for the acquisition and preparation of data for review from multiple sources to prepare Health Hazard Evaluations.

Duties & Responsibilities

Review and classify the data collected as part of Clinical Evaluation Reports, literature reviews and other surveillance activities. Manage outsourced data collection, organization preparation with vendors as required. Support Physicians, such as case series review, data review, draft reports. Assist in organizing or running searches of safety or regulatory databases. Provide support to related PMS activities such as Periodic Safety Update Reports (PSUR) preparation of reports for surveillance supports and collating reports for review of product quality data, support of health hazard evaluations, scientific presentations etc. Participate in preparation, analysis and writing of ad-hoc and aggregate regulatory reports and, labeling support documents.

Qualifications:

• Advanced academic degree in a health-care discipline (e.g. MD, DO, ARNP etc.).
• Previous experience within the medical device or pharmaceutical industry and at least 6-year of post-marketing safety data analysis preferred but not required.
• Familiarity with industry principles of device safety, device development, pharmacology, biostatistics, and epidemiology.
• Basic knowledge of common data processing software.

Other Skills & Abilities.

• Functional knowledge of EXCEL, PowerPoint, Microsoft Word. Team player, ability to work under tight timelines with poise.
• Ability to thrive in a global, matrix environment.
• Ability to manage high workload and critical issues.
• Excellent verbal and written communication skills.

Required Skills:

Preferred Skills:

Clinical Operations, Compliance Management, Compliance Risk, Critical Thinking, Cross-Functional Collaboration, Medicines and Device Development and Regulation, Organizing, Quality Control (QC), Research Ethics, Risk Management, Risk Management Framework, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Tactical Planning, Team Management