Designation: Team Member. Job Location: Mumbai .
5 Days of working
MBBS Freshers can also apply
working days- 5
Shift timings: 6:30am-3:30pm, 9:30am-6:30pm 3:30pm-12:30pm
Preparing Drug Safety Reports
Review and quality control of the serious and expedited cases as well as non-serious cases.
Review all forms and documents pertaining to a case for errors, missing information, legibility.
Provide guidance and medical input to the team members on the adverse event cases and expedited cases.
Ensure drug safety reporting regulations, ICH guidelines, and Client SOPs are applied by the team members to adverse event case reporting
Identify, support, and implement continuous improvement activities
Identifies business development opportunities and communicates them to the Client Account Lead and senior management.
Provide medical expertise and judgment throughout the case-handling process with medical review of individual cases.
Maintain knowledge of the concerned product portfolio
Provide medical expertise and judgment to enable high-quality and timely responses to safety queries.
Drafting the Medical Monitor Comments and the Company Remarks for cases.
Determine the medical significant events.
Resolve queries related to MedDRA coding and solve the Medical queries during case handling.
Client interactions and telecom.
Awareness and adjustment to changing regulatory environment.
Eligibility Criteria :-
(Part time Experience will not be considered).
Minimum 15yrs of regular education (10th + 12th + 3 years Graduation)
Graduates through Open Universities/Correspondence graduates need not apply
Not more than 2 years of gap in Graduation or Employment.
Relieving letters from all the previous companies are mandatory
Candidates who have attended the selection process in the last 6 months will not be eligible to apply again.