Bio Clinica is a specialty clinical trials services provider that improves the development of new medical therapies by delivering expertise and technologies that enhance clinical research data and analytics, worldwide. The company offers industry-leading medical imaging services, enterprise eClinical technologies, safety and regulatory, patient recruitment and retention, clinical research centers and cardiovascular safety solutions that bring quality and efficiency to every phase of clinical development. Bio Clinica's experience spans three decades and includes thousands of studies in all therapeutic areas. Bio clinica serves more than 400 pharmaceutical, biotechnology, and device organizations including all of the top 20 through a network of offices In the U.S., Europe and Asia.
Post : Drug Safty Associates
Job Description:
- Receive information or inquiry through email/fax/mail and create a record in Track Wise and IRMS
- Attach product replacement authorization form in Track Wise, if inquiry involves replacement request
- Follow Track Wise Convention guide while handling and managing product complaints. Receive information or inquiry through email/fax/mail and process them in IRMS
- Generate reports related to inquiries received through email/fax/mail
- Enter all the relevant information received through email/fax/mail into IRMS
- Enter all the information pertaining to non-significant phone emails, faxes for internal tracking and reconciliation
- Responsible for adverse events and for book-in of cases received by all source types (email/fax/mail) into ARIS-g
- Responsible for following good documentation practices while completing AEM form Responsible for triaging of case
- Responsible for attaching AEM form or other source documentation to case.
- Thorough understanding of use of FAQs and product labeling to answer medical information inquiries
- Thorough understanding of regulatory requirements for safety reporting
Candidate Profile: Bachelors Degree in Pharmacy/ Life Sciences or equivalent in a related discipline/Pharm D/Bsc Nursing. 0-2 Year experience in Pharmacy/Clinical research services.
Additional Information:
Experience : 0-2 years
Qualification : Bachelors Degree in Pharmacy/ Life Sciences
Location : Mysore, India
Industry Type : Pharma / Biotech / Clinical Research
Functional Area : ITES , BPO , KPO , LPO , Customer Service , Operations
Last date : 30th July, 2016
Interested candidates are requested to send their profile to Chandana.m@synowledge.com
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