Kelly Services - Pharmacovigilance Medical Director - Alachua, Florida
Kelly Science & Clinical is seeking a Nephrology Medical Director for a fulltime, contract position with a large CRO client. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Remote Position: Candidates must be located on the east coast of the US or be willing to work eastern time zone hours daily.
Fulltime: 40 hours/week
Contract: Long term opportunity, at least 2 years
Summarized Purpose:
Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports (e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR).
Essential Functions:
- Manages all medical aspects of contracted tasks across the pharmaceutical product life cycle.
General Support:
- Ensures tasks delegated to PVG are properly executed.
- Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues.
- Adheres to client SOPs/directives and project specific WPDs for assigned projects.
- Adheres to PPD’s corporate policies and SOPs/WPDs.
- Provides medical consultation to team members and answers all study related medical questions.
- Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
- Provides therapeutic training and protocol training on assigned studies, as requested.
- Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete.
Clinical Trial Support:
- Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies.
- Discusses all medical concerns with principal investigators and clients (e.g. discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study.
- Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported by study sites.
- Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns.
Marketed Products Support:
- Manages signal detection activities, scientifically reviews aggregate reports, contributes to label updates, supports dossier maintenance and risk management activities.
- Medically reviews adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc) as contracted.
Knowledge, Skills and Abilities:
- Therapeutic expertise across one or more medical specialty or sub-specialties.
- Strong decision-making, problem solving, organizational skills and analytical skills.
- Excellent oral and written communication skills.
- Working knowledge of relevant safety databases (e.g. Medra).
- Flexibility to travel domestically and internationally.
- Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information.
- Proficiency in basic computer applications.
- Fluent in spoken and written English.
- Excellent interpersonal, influencing and team building skills.
- Understanding guidelines (FDA, ICH, EMA and GCP).
- Working knowledge of biostatistics, data management, and clinical operations procedures.
- Ability to act as a mentor/trainer to other staff.
Education and Experience:
- MD or equivalent required. Active medical licensure preferred.
- Nephrology experience as a Medical Doctor or Medical Director within clinical research is required.
- Candidates should have at least one of the following:
- Clinical experience in treating patients in the specialty or sub-specialty (Nephrology) associated with the applicants training (comparable to 3 years).
- Or suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 3-5 years) in the industry.
- Or direct experience in safety/Pharmacovigilance (comparable to 3 years).
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
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