Aggregate Writing Physician...m

Job Description :

Overall Purpose of the Job: 

Responsible for the medical assessment, recommendation, and conclusion section of the Aggregate Safety Reports.
Responsibilities/Authorities
Review, conduct analysis and write specific sections in order to draft the final version of aggregate safety reports PSURs, PADERS, SMRs, ASR and INDARs
Create all documents in accordance to all applicable Standard Operating Procedures (SOPs), and conventions 
Plan, organize, and manage daily work to meet service level timelines and deliverables.
Work with the Aggregate Reporting team lead to escalate issues or tasks outside the normal scope of work.


Requirements

MD/MBBS (board certified) as a minimum, a higher medical speciality is preferred;
Good understanding of drug safety;
2 - 4 years experience in a clinical practice;
1.5 - 3 years experience in pharmaceutical industry (PV, clinical Research, and Medical Affairs areas are preferred);
Experience in writing all sections of aggregate reports like PSUR, PADERs, INDARs, ASR, SMR and bridging reports are required
Working knowledge of Volume 9A
Working knowledge of Good Clinical Data Management Practices, ICH Good Clinical Practices, FDA and EMEA investigational and post marketing regulatory guidelines is preferred;
Experience with MS Office products;
Effective communication, organisation and time management skills;
Good interpersonal skills and the ability to operate effectively in an international environment;
English language (written) proficiency is a must



Apply Here - http://www.shine.com/jobs/aggregate-writing-physician/neptune-consultants/1308534/?utm_source=Indeed&utm_medium=organic&utm_campaign=Indeed#