Assoc Dir Medical Safety

Job Overview
Provide medical expertise on pharmacovigilance services to divisions as requested. The Associate Medical Safety Director participates in all aspects of Medical Safetys involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors.

Essential Functions
Perform medical review and clarification of trialrelated Adverse Events (AEs) and postmarketing 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 products 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 benefitrisk 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 Backup 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 medicalsafetyregulatory 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
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
Hold at least bimonthly meetings with direct reports to discuss at a minimum: project status including timelines delivery updates financial aspects of the group or project and potential risks associated mitigation and support required; status of any initiatives that they may be involved in; the teams utilization rates; the direct reports training and other administrative obligations such as Standard Operating Procedures (SOPs) and corporate training mandates; personnel issues; and career or training objectives.
Create and implement plans for measuring and improving employee engagement ensuring global consistency. Maintain open and regular communication with direct reports to ensure a supportive working environment.
Efficiently conveying messages from leadership to direct reports and teams as well as effectively communicating issues and opportunities up to leadership.
Might be needed to serve as the designated substitute or alternatively ensure coverage is in place for direct reports during their absence or in case of turnover.
Prepare present and respond in bid defense meetings and discussions. May input into more complex requests for information (RFIs) or requests for proposal (RFPs). Liaise with Business Development to give timely inputs regarding the feasibility of all new proposals going out to clients.
Contribute at IQVIA internal crossfunctional project team meetings interfacing with other functional leads customer project status meetings and oversight group meetings. Subject Matter Expert (SME) Meetings as appropriate.

Qualifications
Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req
Three 3 years of clinical practice experience (e.g graduate medical training) with two 2 additional years in the pharmaceutical or associated industry in any role. Or equivalent combination of education training and experience Req
Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice
Knowledge of clinical trials and pharmaceutical research process
Strong business acumen; financial management and budgeting skills.
Proven Staff management skills strong leadership motivational and influencing skills.
Strong project management; strategic planning; delegation and organisational skills. Proven ability to work on multiple projects and manage competing priorities.
Confident in raising and discussing sensitive topics without management intervention and in communicating effectively with senior levels of management in both IQVIA and customer organizations.
Demonstrated ability to remain calm and assertive yet diplomatic in more challenging interactions with customers and colleagues.
Excellent communication (both verbal and written) presentation and negotiation skills.
Ability to establish and maintain effective working relationships with coworkers direct reports managers and customers at a senior level.
Autonomous independent decisionmaking; problem solving and judgment skills.
Strong customer focus; account and alliance management and experience in customer contracting models.
Proven ability to professionally network; present and lead at meetings/ teleconferences.
Ability to achieve results through communication facilitation negotiations in a matrix service delivery environment with shared responsibilities.
Demonstrate excellent flexibility; selfmotivation; creativity; innovation and solutions driven approach.
Demonstrates financial awareness. Promotes good practices to manage financial performance
Strong ownership skills: take initiative and move forward with limited guidance.
A valid medical license or equivalent from the country or region in which he/she resides and works Pref

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