Johnson & Johnson Careers

SR SAFETY OFFICER

Cincinnati, Ohio
Drug & Product Safety Science


Job Description

Requisition ID: 0253181214

Position Summary

 
  • The SSO role leads the medical safety function for the Group or assigned business area.  The SSO will have oversight of safety investigations ensuring proactive and timely assessments of safety data, understanding of the emerging and known safety profiles of the products within his/her area, and communication of potential and known risks, when appropriate, to Senior Management, Health Authorities, Prescribers and/or Patients.  The SSO will further be responsible for ensuring alignment to sector Safety processes, policy, and procedures and standards.  The SSO oversees Medical Safety Officers (MSOs)  in his/her assigned area and is responsible for ensuring they complete the designated training for medical safety (to be determined by MD&D Medical Safety Group), and training per the clinical competency model in accordance with their personal development plans.  The SSO must be aware of resources needed to fulfill all medical safety obligations, and partner across the responsible functions to ensure any resource gaps are addressed expeditiously. The SSO is responsible for determining the appropriate delineation of responsibilities between a medical director who is chairing a Safety Management team (SMT) and the assigned MSO who provides an independent medical perspective on medical safety.  The SSO is a member of the Chief Medical Officer’s Leadership team, and a close partner with the quality leader for the assigned businesses. The SSO presents Medical Safety Issues to QRB. The SSO must collaborate with key stakeholders and champion the Enterprise Medical Safety Principles.
 
  • The scope of the role encompasses: [product scope to be determined by the SSO and CMO, MD&D in collaboration with the CMO of the relevant business for each product/product family, and relative allocation of time between different product/product family should be stated].
 
 
Principal Duties & Responsibilities
 

Oversee the assessments of product risk-benefit in partnership with the MSO:

  • Risk Management Reports
  • Health Hazards Evaluations
  • Clinical Evaluation Reports
  • Product Safety Surveillance plans (SSPs), including risk categorization of product/product families
Ensure MSO input is provided to :
  • Responses to AEs, complaints and mass communications
  • Internal and customer safety training materials
  • Design and interpretation of safety related studies, and results of any SSP activities
  • Evaluation of medical impact of manufacturing issues
  • Product’s harms and hazards list and derivations of criteria for reportability
  • Failure investigations

Serve as an expert resource to MSOs for the interpretation of:

  • Post-marketing safety data
  • Aggregate complaint data
  • Individual case safety reports
  • Literature reports with possible safety data
  • Ensure all medical personnel (MDs, MSOs, regional MDs) in the assigned area understand their role in medical safety
  • Be the responsible medical safety representative at QRB for any product safety related escalations, partnering with Medical Director, MSO and Quality Risk management
  • Ensure consistency in medical evaluations, Quality Review Board decisions and overall safety evaluations of products
  • Ensure appropriate metrics are used to assess adequacy of patient safety related processes
  • Deploy best practice in co-ordination with MD&D CMO
  • Coordinate presentations to the MD&D medical Safety Council for product safety issues for assigned products
  • Work in partnership with MD&D SSOs and MD&D Medical Safety group to enhance organization effectiveness, and support professional development for MSOs and Medical Directors

This is not an exhaustive, comprehensive listing of job functions.  May perform other duties as assigned by the Chief Medical Officer, MD&D



Qualifications
Education and/or Experience
 
  • Doctor of Medicine, (MD), Doctor of Osteopathy (DO) designation or equivalent, such as MBChB
  • Minimum of 3 years clinical experience
  • 10 years or more clinical, pharmaceutical and/or medical device experience
  • Experience in risk evaluation and mitigation
  • Experience in matrixed organizations
  • Medical device and/or pharmaceutical industry experience
  • Clinical study/research experience
  • Experience of interfacing with senior leadership within a global healthcare company
 
Other Skills & Abilities
 
REQUIRED TECHNICAL KNOWLEDGE & SKILLS:
  • A knowledge of basic statistical techniques
  • A knowledge of basic epidemiological principles
  • Advanced statistical knowledge (e.g. multivariate data analysis)
  • Advanced Microsoft Excel skills
  • Training or significant experience in surgery
  • Medical training in surgery
 
 


Primary Location
United States-Ohio-Cincinnati-
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Drug & Product Safety Science
Requisition ID
0253181214