Hiring for Leading companies -Assoc Medical Safety Dir

Job Description:

Sub-Family Description
Provides medical, scientific, and therapeutic expertise on pharmacovigilance services.
Participates in all aspects of the Medical Safety activities as per scope of work, such as performing medical review
and clarification of trial-related Adverse Events including review of analysis of similar events, medical evaluation of
post-marketing adverse drug reactions, review medical inputs for into signal management and benefit-risk
evaluation of drugs in clinical trial and post marketing set up, safety aggregate report review, safety review of
study protocol, investigators brochure and other reference safety information, clinical study report narrative
review, providing medical assessment comments etc and serving as an internal consultant for any medical support
for pharmacovigilance operations.
JOB OVERVIEW
Job Profile
Provide medical expertise on pharmacovigilance services to divisions as requested. The
Associate Medical Safety Director participates in all aspects of Medical Safety’s involvement.
on assigned trials and stand-alone safety projects with appropriate oversight from management or more senior
medical safety directors.
Responsibilities
Essential Functions
• Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug
reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company
summary
• Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based
on regulatory requirements
• Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
• Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s
safety profile
• Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to
verify and medically vet clinical data
• Represent safety and clinical data review findings during client meetings
• Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic
Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports
• Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk
Evaluation and Mitigation Strategies
• Provide medical oversight for label development, review and change
• Provide medical support and attendance at Data Safety Monitoring Board Meetings
• Attends and contributes medical safety evaluation on Safety Monitoring Committees
• Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document
• Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments
• Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope
agreed in contract
• Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms
(CRFs) for appropriate safety content and data capture.
• Act as Global Safety Physician or Assistant or Back-up on projects as assigned
• Attend project meetings, medical safety team meetings, and client meetings as requested

• Ensure coverage for all medical safety deliverables within regulatory or contracted timelines
• Provide medical escalation support for medical information projects
• Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects
• 24 hour medical support as required on assigned projects
• Maintain awareness of medical-safety-regulatory industry developments
• Line manage a team of regionally based physicians performing the tasks of a global medical safety physician
ensuring operational delivery of assigned projects and professional development of direct reports
• Account for financial performance of assigned medical safety projects
• Evaluate assigned staff workload and volume projections in order to ensure appropriate balance of project
assignments for direct reports
• Ensure appropriate resourcing and coverage of assigned global projects, regardless of regional holidays
• Ensure that departmental goals, objectives, policies, and procedures are communicated, understood, and
implemented
• Supervise assigned direct reports and provides mentoring as required; identifying ongoing training and
development needs of assigned staff
• Recommend course of action on management/human resources matters, including salary administration,
transfers, hiring,
terminations, professional development, performance appraisals, and employee counseling
• Participate in the Global Medical Safety Management Team to drive service line growth, differentiation, and
strategy
• Represent global medical safety service line to regional stakeholders, internal and external
• Attend key meetings pertinent to service line and maintain connections with key clients of service line
• Serve as a resource and participate in strategic business development activities including presentations to
prospective clients,
professional meetings, and other business development activities
• Perform special projects as requested by management

Education
Other A medical degree from an accredited and internationally
recognized medical school with a curriculum relevant to
general medical education