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1.0 - 6.0 years
0 Lacs
pune, maharashtra
On-site
You will be responsible for responding to medical information queries, product quality complaints, and general queries received through various channels such as telephone calls, emails, and faxes. Additionally, you will receive, record, and report Adverse Drug Reactions in a timely manner, adhering to regulations and internal work instructions and standard operating procedures. Your role will involve executing drug safety data management processes, including call intake, documenting call dialogues, peer review, and case follow-up. You will also support various activities such as tracking information and metrics, quality control of process steps, training, and data reconciliation from multiple sources. Creating and updating training materials based on procedural, system, and regulation changes will also be part of your responsibilities. You will conduct trainings and evaluate their effectiveness as required, ensuring the quality of processed data. Additionally, you will undertake any other duties as assigned by management. To qualify for this position, you must have a Bachelor's or Master's degree in Pharmacy, Life Science, Medical Science, or a related field, along with 2 to 3 years of safety experience. Alternatively, a BS/BA with 2 to 3 years of safety experience, MA/MS/PharmD with 1 to 2 years of safety experience, Associate degree with 4-5 years of relevant experience (including 2+ years of safety experience), or non-degree with 5-6 years of relevant experience (including 2+ years of safety experience) will be considered. Fortrea may also accept relevant and equivalent experience in place of educational qualifications. Safety experience should encompass processing Adverse Event/Serious Adverse Event reports, creating narratives, handling queries, working with safety databases, and involvement in regulatory submissions. Relevant experience in the pharmaceutical, biotechnology, or CRO industry, particularly in areas like Medical Affairs, Clinical Data Entry and Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance, will be beneficial. Proficiency in English, both written and verbal, is required. Your experience in call center operations will be advantageous for this role. Preferred qualifications include a degree in Biological Sciences, Pharmacy, Nursing, Life Sciences, or Chemistry, though it is not mandatory. Strong written and verbal communication skills are essential, along with the ability to handle inbound and outbound calls, analyze medical information, and understand regulatory requirements, Pharmacovigilance practices, and ICH GCP guidelines. Proficiency in Microsoft Office applications, attention to detail, teamwork, and the ability to work independently with moderate supervision are also important attributes for this position.,
Posted 2 weeks ago
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