Medical Dir
- Employer
- Labcorp
- Location
- London, United Kingdom
- Salary
- Competitive
- Start date
- 28 Aug 2019
- Closing date
- 19 Sep 2019
View more
- Discipline
- Medical Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Education/Qualifications:
- Responsible for 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 required by global regulatory agencies for review of safety information for assigned products.
- 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.
- Provides medical/safety expertise to project teams, including communicating information regarding drug safety regulations and any changes that have occurred
- Participates in training opportunities to advance knowledge of pharmacovigilance as it relates to drug/product development and drug/product marketing utilizing good clinical practice guidelines
- Provides pharmacovigilance support to project physicians, as appropriate
- Participates in project risk assessment activities
- 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
- Assists in the preparation of pharmacovigilance materials for investigator meetings
- Provides mentoring to and responsible for supervision of Associate Medical Directors and Senior Managers, and mentoring to and indirect supervision of Senior Drug Safety Associates, and Drug Safety Associates
- Ensures adequate coverage of all project related duties
- Presents pharmacovigilance capabilities to clients as a participant of a proposal team, when appropriate
- Develops new and enhances existing client relationships whenever possible
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
- Substantial knowledge of pharmacovigilance and the global regulations governing drug/biologics/device safety activities both during clinical development and during the postmarketing phase of lifecycle management.
- At least 3 years of experience in pharmacovigilance & risk management working either for a pharmaceutical company, health authority or a contract research organization
Company
At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.
- Website
- https://careers.labcorp.com/global/en
- Location
-
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom
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