Reporting to the Senior Medical Director, the incumbent will be largely responsible for the medical review of serious adverse events derived from clinical trials, in support of drug safety activities for clients.
When applicable, responsible for preparation and medical review of Aggregate Reports (Periodic Safety Update Reports PSURs, Periodic Adverse Drug Experience Reports PADERs) required by global regulatory agencies for review of safety information for assigned products, when authorized to perform this function on behalf of a client.
When applicable, responsible for signal detection and evaluation activities and preparation and submission of Ad Hoc Reports reviewing specific safety issues to the global regulatory agencies for assigned products, when authorized to perform this function on behalf of a client.
Participates in training opportunities to advance knowledge of pharmacovigilance and serves as a consultant on pharmacovigilance issues to the project physician
Provides medical / safety expertise to project teams, including communicating information regarding drug safety regulations and any changes that have occurred
Assists in the preparation of pharmacovigilance materials for investigator meetings
Assumes responsibility for medical and safety monitoring on assigned projects
Provides mentoring of and indirect supervision of Senior Drug Safety Associates, and Drug Safety Associates
Responsible for communicating status of projects and other activities to the Senior Medical Director (Lead) and others as appropriate.
Experience : Required for Associate Director level : (115)
At least 2 years of experience working either for a pharmaceutical company, health authority or a contract research organization in related fields such as QA, Regulatory Affairs, medical writing, PCS, TM or clinical medical monitoring
Education / Qualifications / Certifications and Licenses :
MD or DO with at least one year of postgraduate training or equivalent.
MD who has completed an accredited residency program or equivalent and is board-eligible or certified with at least 4 years experience with substantial knowledge of drug safety and the global regulations governing pharmacovigilance and risk management
Required : Strong communication (oral and written English) skills
Good interpersonal skills
Ability to work independently and in teams
Good prioritization skills
Ability to adjust to changes in tasks as required
Ability to provide leadership and guidance to indirect reports Senior Drug Safety Associates and Drug Safety Associates
Ability to represent the company at client, industry and medical meetings
Travel Requirements : Yes ; Up to 20% of time
Language Skills Required :
Speaking : Yes No English at ILR level 3+ or higher
Writing / Reading : Yes No English at ILR level 4 or higher
Labcorp is proud to be an Equal Opportunity Employer :
As an EOE / AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.
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