Company Profile:
iMEDGlobal
iMEDGlobal is an innovation driven company providing platforms, services and solutions to global life sciences clients addressing their critical business and scientific needs. Our platforms, services and solutions include Pharmacovigilance, Regulatory Affairs and Clinical Research. iMEDGlobal's corporate office is based out of Princeton, NJ and have offices in Philippines & India.
Job Description
Roles & Responsibilities:
1) Manage and perform the Quality review process for aggregate reports within scope (which may include but are not limited to PADER, PBRERs, PSURs, SMR, SBRs, Any adhoc reports for the assigned products - small to high complexity reports, including planning, conducting planning meeting, coordinating of production modification, assembly in the Database, as appropriate
2) Develop robust checklist to ensure Various sections are completed from the concerned departments
3) Ensure template is followed, develop templates as appropriate
4) Ensure preparation of timely, quality aggregate reports for assigned products
5) Liaise with relevant stake holders as appropriate for preparing report content.
6) Data quality review /correction
7) Attend team meeting, department meetings, required training and relevant activities.
Desired Candidate Profile
Education-
UG: Any Graduate - Any Specialization, B.Sc - Any Specialization, Bio-Chemistry, Biology, Botany, Chemistry, B.Tech/B.E. - Any Specialization, Bio-Chemistry/Bio-Technology, Biomedical
PG:Any Postgraduate - Any Specialization, Post Graduation Not Required, M.Pharma - Pharmacy, M.Sc - Any Specialization, Bio-Chemistry, Biology, Chemistry, M.Tech - Any Specialization, Bio-Chemistry/Bio-Technology, Biomedical
Doctorate:Doctorate Not Required
- Essential Skills Required and Education:
1) Masters degree or equivalent in Pharmacy/MBBS/Any Medical Degree. Board Certification is preferred.
2) 2-5 years related experience. (AR, complaints handling, clinical study, marketed product safety, relevant clinical exposure / practice for MDs, scientific writing or editing experience). Actual 2-3 Years AR writing experience is a plus.
3) Awareness of global regulatory requirements and drug safety
4) Drug safety familiarity (case management, spontaneous solicited and clinical, familiarity with safety database)
5) Writing experience and competence (samples and extemporaneous)
6) Excellent verbal and written communication skills (formal, e-mail and teleconference) ability to communicate in global environment
7) Microsoft word competence (tables and basic formatting)
8) Good interpersonal and communication skills and the ability to operate effectively in a global environment
9) Thorough understanding of Regulatory guidelines
10) Ability to work independently, demonstrating initiative and flexibility
11) The ability to work in a matrix environment with cross-functional global teams is essential
Recruiter Name:Sucharita
Contact Company:iMEDGlobal
Website:http://www.imedglobal.com
Telephone:7022894140
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