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PPD

Medical Director (Home-based or Office-based)

Medical Director, M-SERM (Medical Safety Evaluation and RiskMitigation) group

The primary responsibilities of this position include medical review andanalysis for clinical trial serious adverse events, marketed products ICSR andperiodic safety reports (e.g. PBRER, PSUR, DSUR), as well as other clientdeliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP,Signal detection reports and CSR). This individual will also serve as the groupliaison with other PPD groups and clients.

Job Qualification:

Education and Experience:
  • MD or equivalent required. History of an active medical license highly preferred. Candidates should have at least one of the following:
    • Clinical experience in having direct responsibility for diagnostic and treatment decisions (comparable to 2 years) AND direct experience in medical review and assessment of safety information/Pharmacovigilance (comparable to 3 years); Or
    • Direct experience in medical review and assessment of safety information/Pharmacovigilance (comparable to 5 years).


Knowledge, Skills and Abilities:
  • Fluent in spoken and written English
  • General medical knowledge of diagnostic and therapeutic approaches across multiple specialties. Therapeutic expertise across one or more medical speciality or sub-specialities preferred.
  • Strong decision-making, problem solving, organizational skills and analytical skills
  • Excellent oral and written communication skills
  • Excellent interpersonal and team building skills
  • Consultant level knowledge of guidelines (FDA, ICH, EMA and GCP)
  • Understanding of basic biostatistics, data management, and clinical operations procedures
  • Excellent organizational skills
  • Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information
  • Working knowledge of the drug development process and thorough understanding of guidelines for marketing authorization submissions and international guidelines for conduct of clinical studies
  • Consultant level knowledge of clinical program and study design, relevant endpoints, safety considerations, and current regulatory and commercial landscape.
  • Consultant level knowledge of marketed products pharmacovigilance regulations
  • Consultant level knowledge of Drug Safety Dictionaries (e.g. MedDRA)
  • Working knowledge of relevant safety databases (e.g. ARGUS, ARISg)
  • Ability to act as a mentor/trainer to entry level peers and managerial level staff within the Pharmacovigilance Department
  • Flexibility to travel domestically and internationally
  • Proficiency in basic computer applications
  • Ability to serve as the group liaison with other PPD groups and clients


Working Conditions and Environment:
  • Work is performed in an office environment with exposure to electrical office equipment
  • Occasional drives to site locations with occasional travel both domestic and international


Physical Requirements:
  • Frequently stationary for 6-8 hours per day
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
  • Frequent mobility required
  • Occasional crouching, stooping, bending and twisting of upper body and neck
  • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf
  • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences
  • Frequently interacts with others to obtain or relate information to diverse groups
  • Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration
  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task
  • Regular and consistent attendance

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Diversity Statement

PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.

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