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Assoc Medical Dir – MD

Labcorp

Labcorp is transforming how patients are diagnosed, monitored, and treated.

  • Responsible for medical review of serious adverse events and nonserious adverse events from clinical trials and postmarketing surveillance in support of drug safety activities for clients.
  • Reviews laboratory values, adverse events, coding dictionaries and data tables, listings and figures as needed to identify drug safety issues in collaboration with the project physician
  • 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:

  • Required: MD or DO with at least one year of postgraduate training or equivalent.
  • Preferred: 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

Competencies:

Required: Strong communication (oral and written English) skills

Good interpersonal skills

Well organized

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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Assoc Medical Dir – MD

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Labcorp

Labcorp is transforming how patients are diagnosed, monitored, and treated.

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