What are the responsibilities and job description for the Aggregate Report Specialist position at Actalent?
Description:
• Preparation and review of safety assessments and evaluations for ad hoc regulatory safety reports such as responses to health authority’s requests, health hazard evaluation. • Write and review various safety reports (or safety portions of such reports) for global regulatory submissions for Labcorp’s clients, including Periodic Safety Update Reports/ Periodic Benefit Risk Evaluation Reports, Periodic Adverse Drug Experience Reports, Bridging reports and other documents as assigned • Author/review RMP, ad hoc reports, Safety Update reports, Benefit-Risk Evaluation, CCDS supporting document, ACOs, Addendum reports • Preparation of safety review to address specific safety issues • Efficiency in conducting literature searches for authoring various types of reports Search literature databases for relevant information, recommend label changes, author proposed label text and preparation of supporting/justification document • Coordinate activities related to various types of report writing across a team of writers if applicable • Liaise with client and act as a primary point of contact for all report writing activities • Act as a writing coach and devise training programs • Impart/conduct Trainings for peers and team members • Author/review SOPs/WIs/process documents or sections as applicable • Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables • Ensure compliance of operations with governing regulatory requirements • Create, maintain and assume accountability for a culture of high customer service • Perform various support activities such as tracking, maintenance of metrics, performing and documenting quality checks and training • Internal and external (client) communication & co-ordination to get the required inputs • Get resolution on issues affecting project deliverables • Any additional activities as per the project requirement or manager’s discretion on completion of relevant trainings • Ability to work independently with minimal to no guidance.
Skills:
Analytical skill
Top Skills Details:
Analytical skill
Additional Skills & Qualifications:
Disqualifiers: • If majority of the pharmacovigilance/drug safety experience is in case processing • If the candidate has only coordinated activities for aggregate reports and copy pasted data in the report.
Experience Level:
Expert Level
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Salary : $50 - $65
