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10 Dec. 11, 2024
Job Description
Job Type: Full Time 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

Job Title: Global Medical Safety Lead

Work Schedule: Standard (Mon-Fri)

Environmental Conditions: Office-based

Location: [Insert Location]


Job Description

As a Global Medical Safety Lead at our organization, you will take a strategic leadership role in assessing medical safety data for assigned products. You will develop and execute safety signaling and benefit-risk management strategies while collaborating closely with both internal and external stakeholders to ensure the safe use of products. This includes aligning safety communications and managing safety data with key teams and regulatory agencies.


Roles and Responsibilities

  • Provide strategic medical safety leadership for assigned products in a cross-functional setting.
  • Perform safety signal management and benefit-risk assessments, including regular and ad-hoc aggregate safety data reviews for assigned products.
  • Lead cross-functional teams to conduct reviews of emerging safety data for assigned products.
  • Contribute to the development and execution of the safety governance structure and related activities.
  • Deliver timely, accurate, and high-quality safety contributions for regulatory submission documents (e.g., ISS, SCS, narratives).
  • Review and/or prepare safety sections of clinical and regulatory documents, including study protocols, Investigator Brochures (IBs), Clinical Study Reports (CSRs), and Informed Consent Forms (ICFs).
  • Provide safety support for responses to regulatory authority inquiries, ensuring the completeness and accuracy of safety information.
  • Lead the preparation of periodic safety reports (e.g., PSUR, DSUR), ensuring medical safety content consistency and quality.
  • Oversee the medical assessment of Individual Case Safety Reports (ICSR) and ensure proper criteria for expedited reporting.
  • Contribute to the preparation of safety presentations for Data Safety Monitoring Boards (DSMB).
  • Participate in internal audits and regulatory inspections with a focus on medical safety.
  • Support the development and updates to Standard Operating Procedures (SOPs) and other controlled documents related to pharmacovigilance.
  • Assist in pharmacovigilance awareness activities and training across functions.
  • Support the creation and maintenance of pharmacovigilance agreements with clinical or commercial partners.
  • Collaborate across teams on various pharmacovigilance initiatives.

Skills and Competencies

  • Strong scientific and analytical skills.
  • Ability to manage multiple tasks in a fast-paced environment.
  • Demonstrated leadership and team collaboration skills.
  • Exceptional presentation and communication skills, with the ability to simplify complex issues.
  • Proficiency in Microsoft Office and relevant computer systems.

Education, Experience, and Qualifications

  • MD degree or equivalent required.
  • At least 7 years of relevant experience in the pharmaceutical/biotech industry, with 5 years in pharmacovigilance/drug safety (global experience preferred).
  • Minimum 1 year of clinical practice or experience in academic medicine.
  • Working knowledge of pharmacovigilance regulatory requirements and guidance.
  • Experience with medical assessments of safety data from multiple sources.
  • Proven ability in authoring complex documents and contributing to regulatory submissions.
  • Experience in epidemiology, biostatistics, clinical development, or medical affairs is an advantage.

Application Process

If you meet the qualifications and are interested in this opportunity, please apply today!

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