BIOCLINCA INDIA WALKIN DRIVE DETAILS
|Company Name||Bioclinca India Pvt Ltd|
|Qualification||B.Sc, M.Sc, B.Pharma, M.Pharma, BHMS, BDS, BAMS|
|Experience||0 – 1 Year|
|Salary||Not Disclosed by Recruiter|
|Industry||Pharma, Biotech, Clinical Research|
Bioclinca Job Description
- Job Title: Drug Safety Associate
- Work Location: Mysore
- Qualifications: M Pharmacy, Pharm D, B.Sc, M.Sc Nursing, BDS, MDS, BAMS, BHMS, BPT, MP.
Bioclinca Duties And Responsibilities
- Responsible for case intake, duplicate check, and registration.
- Maintain a log of source documents and other communications.
- Full data entry including medical coding and safety narrative.
- Responsible for data entry of individual case safety reports into the safety database.
- Process all incoming cases in order to meet timelines.
- Review and evaluate AE case information to determine a required action based on and following internal policies and procedures.
- Responsible for coding all medical history, events, drugs, procedures, indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD).
- Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.
- Ensure effective and accurate collection, recording, review, and reporting of literature searches conducted.
- Review of literature articles to identify case safety reports.
- Create, maintain study summary documents.
- Assist in signal generation and safety analysis activities.
- Ensure quality of literature searches and reporting.
- Responsible for operational Pharmacovigilance activities for assigned developmental and/or marketed products.
- Review of local, global literature reports to determine regional reportability.
- Assist with ad hoc or routine safety monitoring activities.
- Assist with narrative writing for periodic, ad hoc submissions.
Bioclinca Job Responsibilities
- Following up with sites regarding outstanding queries.
- Follow departmental AE workflow procedures.
- Perform literature review activities when trained and assigned.
- Closure and deletion of cases.
- Follow up on reconciliation of discrepancies.
- Perform any other drug safety related activities as assigned.
Bioclinca Required Knowledge And Skills
- Basic competence with medical and therapeutic terminology.
- Able to work effectively as part of a team.
- Ability to work independently but guided by documented procedures, with appropriate support.
- Ability to deliver within established timelines.
- Fluency in English and excellent comprehension.
- Computer literate.
- Understanding of patient safety regulatory obligations.
- Experience with relevant software applications.
- Should be familiar with regulatory & pharmacovigilance guidelines.
- Should be familiar with pharmacovigilance terminology.
- Excellent attention to detail.
- Relevant product and industry knowledge.
Bioclinca Company Profile
How To Apply For Bioclinca Job Vacancies
Bioclinca Walkin Details
Walkin Date: 12th August 2017
Walkin Time: 9:00 AM Onwards
Elephant Rock Road, Jayanagar 3rd Block,
Bangalore – 560 011.
Required Documents Need To Carry For Interview
- 1 Hard copy of your updated resume.
- Recent passport size photographs.
- Candidates must carry their Identity cards.
- Original government ID Proofs.
- All Educational Certificates photocopies.