Openings for Drug Safety Associate – B Pharmacy / Life Sciences – US Shifts @ Bioclinica
JOB TITLE: Drug Safety Associate, PV Services
LOCATION: Mysore, India.
SHIFT TIMINGS : US SHIFTS (with Cab facility)
YEARS OF EXPERIENCE: 0-2 years
B Pharmacy / Bachelor’s / Master’s in Science / Bioinformatics / Biochemistry / Biomedical / Biotechnology / Clinical Microbiology / Medical Biotechnology / Biological Science / Biomedical Sciences / Biosciences / Life Sciences / Medical Biochemistry / Medical Microbiology / Molecular Biology / Clinical Research / Biophysics / Medicinal Chemistry / Nuclear Sciences) or equivalent in a related discipline
ESSENTIAL DUTIES AND RESPONSIBILITIES:
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 calls, 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 of Bioclinica on daily basis.
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
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
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.
DESIRED TECHNICAL SKILLS:
Person should be familiar with MS Office Tools
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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