Job Description
JOB TITLE: DRUG SAFETY ASSOCIATE - MICC
WORK LOCATION : MYSORE
SHIFT TIMINGS : US SHIFTS ( WITH CAB FACILITY)
EXPERIENCE : NONE REQUIRED
TIME : 9 AM to 1 PM
EDUCATION: GRADUATION / POST GRADUATION IN LIFE SCIENCES / HEALTH CARE OR EQUIVALENT
ROLE
Receive information or inquiry through phone call/email/fax/mail and create a record in Annexures. Follow the documentation guidelines on AE/PC/MI calls. Enter all the information pertaining to significant phone caIIs, emails, faxes, mails for internal tracking and reconciliation. Responsible for receiving phone calls related to AE/SAE, product complaints and medical information received by all source types (phone call/email/fax/mail). Responsible for following good documentation practices while documenting information in Annexures. Responsible for preparing, checking and forwarding all case annexures to drug safety division Responsible for performing follow-up with the consumer/reporter whenever required. Thorough understanding of use of FAQs and product labeling to answer medical information inquiries Thorough understanding of regulatory requirements for safety reporting
OTHER RESPONSIBILITIES:
Follow departmental AE workflow procedures Perform any other drug safety related activities as assigned
SPECIALIZED KNOWLEDGE AND SKILLS:
Basic competence with medical and therapeutic terminology Understanding of Patient Safety regulatory obligation Good attention to detail Ability to deliver within established timelines Fluency in Spoken and written English and excellent comprehension
COMMUNICATION SKILLS:
Requires a proactive approach and excellent written/oral communication and interpersonal skills. Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective cross departmental communication. Ability to document and communicate problem/resolution and information/ action plans.
OTHER SKILLS:
The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrate flexibility within a dynamic, fast-paced, cross-functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment. Ability to perform under stringent time lines.
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