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Job Overview:Are you ready to redefine what’s possible, and discover your extraordinary potential at LabCorp? A career here provides the unique chance to create a lasting impact and difference in our patient’s lives. Joining our team will offer you a rewarding career, an opportunity to work in a high-energy & collaborative workplace, along with access to comprehensive benefits. Your work will be meaningful, the patient outcomes are real, and the results are lasting. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.Our mission is to help our clients bring the miracles of medicine to market sooner join us for your next career move.Project Manager - Drug SafetyProvide leadership and management of global or regional projects ensuring that communications and processes are harmonized for assigned projects.
Monitor and manage the workflow for assigned projects to ensure all deadlines are met and compliant safety reporting in accordance with International reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set for
Provide leadership and management of global or regional projects ensuring that communications and processes are harmonized for assigned projects.
Monitor and manage the workflow for assigned projects to ensure all deadlines are met and compliant safety reporting in accordance with International reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team.
Responsible for making decisions regarding adverse event reporting within the guidelines of each assigned project.
Work closely with the clinical operations and project management groups to ensure all PSS activities are performed according to the regulatory and contractual requirements.
Provide oversight of the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial for assigned projects.
Provide oversight of the management and processing of expedited safety reports (ESRs) for assigned projects.
Responsible for making decisions regarding adverse event reporting within the guidelines of each assigned project.
Work closely with the clinical operations and project management groups to ensure all PSS activities are performed according to the regulatory and contractual requirements.
Provide oversight of the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial for assigned projects.
Provide oversight of the management and processing of expedited safety reports (ESRs) for assigned projects.
Education/Qualifications:Minimum Required:Compliance with client and global regulatory requirements
Good knowledge of the relevant worldwide pharmacovigilance regulations and guidelines.
Good knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
Good knowledge of ICH guidelines.
Good knowledge of medical and drug terminology
Work collaboratively with PSS Management’s team
Good verbal, written and presentation skills.
Good communication.
Leadership capabilities
Anticipate/identify problems and takes appropriate action to correct.
Knowledge of Medical Device Reporting desirable
Knowledge of aggregate reporting
Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.
Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
Financially intuitive
Experience:Level of education required (or experience level which may be substituted for level of education).Professional designations/certifications/licenses requiredNon-degree + 6-7 yrs safety experience
Associate degree + 5-6 yrs safety experience
Associate degree RN + 5-6 yrs safety experience
BS/BA + 4-5 yrs safety experience
MS/MA + 3-4 yrs relevant experience (2-3 yrs safety experience)
PharmD + 2-3 yrs relevant experience (1-2 yrs safety experience)
For PharmD, a one-year residency of fellowship can be considered relevant experience.Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.EudraVigilance Certification preferred
