Assoc Dir, Medical Safety

• 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.
• 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
• 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 bi-monthly 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 cross-functional 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 decision-making; 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; self-motivation; 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