Junior Associate - Pharmacovigilance ( Voice Process)
Company - Tata Elxsi
Mumbai, Maharashtra, India (On-site)
Full-time · Entry level
Information Technology & Services
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Job Description
POSITION SUMMARY:
- A Junior Associate- Pharmacovigilance Voice Process is a valuable asset that helps in capturing potential adverse reactions of a medicinal product, registers product complaint on behalf of the consumers and facilitates response to product and medical inquiries.
- The associate holds knowledge in safety services for global clinical studies and post marketing products including safety case intake, case processing, safety surveillance, development of global PV offerings, work models and standards.
- A Junior Associate supports Tata Elxsi Pharma vertical in PV domain, strengthen existing domain capabilities and competencies and develop new domain capabilities.
RESPONSIBILITIES:
- To take telephone calls from consumers/ patients/ HCPs from the US and European regions in a professional and courteous manner.
- Identify the customer concern and follow the adverse event, product complaint or medical enquiry call script as applicable.
- On receipt of patient call, search computerized patient records, checking patient details and patient confidentiality and create initial or follow up case as applicable.
- Maintaining confidentiality at all times with particular reference to patient confidentiality and Data Protection Act.
- Identify callers requiring an immediate emergency response and refer to appropriate department.
- Taking care of rapid and timely processing of new and follow-up reports of adverse events as well as Serious Adverse Events (SAE’s) both from Post-marketing safety programs and Clinical Trials, Product Complaints and Medical Inquiries.
- Performs outbound calls as per agreed process.
- Quality check of the information filled in the case in the safety database.
- Ensure that the productivity targets are met and delivered within timelines.
- Understand and comply with Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, Good Clinical Practices (GCPs), ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study plans and the drug development process.
- Solve routine problems as per general guidelines.
- Advise the Team Leader of any problems and take appropriate action as directed.
- Knowledge of basic statistics for analyzing complaints and adverse event trends.
- Participates in audits and inspection as required.
- Ensure compliance to Client and Tata Elxsi trainings.
- Responsible to deliver any additional task/duties as assigned by the supervisor.
- Ensure timely completion of training file
SKILLS AND QUALIFICATIONS:
- Education: Master/ Bachelor in Pharmacy, Medicine, Nursing or Alternative medicine
- 0-2 years of experience in Pharmacovigilance is must
- Excellent spoken English and ability to communicate to callers from the US and European regions without MTI influence
- Good understanding of medical terminologies and human anatomy
- Basic understanding of safety database, regulatory dictionaries like MedDRA and WHO Drug Dictionary, drug safety regulations, industry practices and standards
- Familiar with good pharmacovigilance documentation, clinical practices and ICH-GCP guidelines
- Ability to work across various domains - planning & prioritizing, tracking monthly matrices and creating dashboards
- Proficiency in Microsoft Office Suite (Word, Excel, Teams and PowerPoint)
- Strong attention to detail, ability to multi-task and deliver on deadline
- Able to maintain up-to-date knowledge in area of practice
- Ability to apply effective interpersonal, verbal, and written communication skills
- Ability to work independently and in a multi-cultural team environment.
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Tags:
PHARMACOVIGILANCE