Medical Director - Post Marketing

This position is responsible for medical management of post-marketing adverse events and medical oversight of safety projects to ensure that company SOPs, sponsor directives, and regulatory requirements are consistently followed. Other responsibilities include 1) medical review of safety reports and associated QA documentation; 2) compilation and preparation of periodic safety reports, as required; and 3) consultative support on issues that directly impact the functioning of the post-marketing safety unit (e.g. staffing, pricing, workflow, safety database utilization).


EDUCATION AND EXPERIENCE:

.MD or equivalent
.Minimum 2 years experience as a Medical Doctor


KNOWLEDGE, SKILLS AND ABILITIES:

.Clinical experience/knowledge of a wide range of diseases and pharmaceutical agents
.Knowledge of PPD Medical Communications? SOPs and corporate policies
.Knowledge of FD&C Law, 21CFR, and FDA safety guidelines and guidance documents
.Knowledge of various ICH safety reporting requirements and CIOMS Working Groups reports
.Ability to teach, mentor, and perform job functions of Product Safety Specialists & Research Assistants
.Working knowledge of biostatistics, and data management
.Ability to simultaneously handle multiple complex issues for multiple projects and/or clients
.Ability to work both as a ?team player? with a high degree of independence
.Ability to work with a high degree of independence in decision-making and problem-solving
.Strong attention to detail
.Effective analytical and problem-solving skills, using creativity and judgment in resolving issues
.Good writing and critiquing skills for preparing, reviewing and critiquing reports
.Good understanding of business and accounting principles
.Excellent written and oral communication skills
.Good presentation skills, including familiarity with Power Point
.Strong knowledge of safety platforms (e.g. ARISg, ARGUS, Oracle AERS, Clintrace)

PPD is an Equal Opportunity EmployerAdditional?InformationSalary:?Competitive Salary & Benefits Package AvailablePosition?Type:?Full Time, EmployeeRef Code:?11851Contact?InformationRTPPPD