
Pharmacovigilance - Medical Information Call Center - Remote / US shift
2 weeks ago
Pharmacovigilance - Medical Information Call Center - Remote / US shift
A Call Agent/ Call Handler/ MI Associate is required to perform PV Global MICC activities, ensuring accuracy, quality, and compliance with procedures.
- Handles inbound and outbound calls for AEs, PQCs and MIs or any of these combinations including but not limited to medical device complaints, legal complaints, product information, medication errors and special case scenarios.
- Identify and retrieve relevant medical and scientific data information, appropriate to answer the information requested by consumer/ health care professionals.
- Respond in a timely manner to web-based medical inquiries (e-mails) and product complaints received from HCPs and consumers, concerning the safety and effective use of all marketed products and Investigational products.
- Work in rotational shifts, if needed to provide 24*7 customer support or as described within the scope defined by the customer.
- Receive and document cases in a MICC tool/ Excel sheet based on the customer agreement and approval.
- Follow-up directly with patients/ consumers and HCPs regarding MI/PQC/AEs queries to gather additional information for appropriate assessment and risk evaluation of the customer products.
- Generate and compile queries on an email template (if applicable) for follow-up and send it to quality reviewer for approval.
- Generate follow-up queries, if required as per project specific guidelines.
- Seek medical reviewer’s opinion where applicable in liaison with quality reviewer/ senior medical information associate/ Designee.
- Update the FAQs list in case new additional information is provided by the customer on monthly/ quarterly/ half yearly/ annually basis (after customer review and approval).
- Once the forms/ documentation is completed, the call agent has to send the information for Quality Check (QC) review via e-mail or submit it through tool as applicable.
- Conducting Monthly Quality reviews of MICC cases for accuracy, quality, and overall process compliance.
- Evaluating performance using key metrics such as accuracy and call-waiting time.
- Demonstrating competency in medical and therapeutic terminology.
Additional Responsibilities
- Follow both global and local regulations to protect personal and client related data as per company policy.
- Be responsible for receiving calls/Email (AE, PQC, MI & GI), case intake, duplicate check, and registration
- Follow up Inquiry through phone, email including translation of inquiry if not in a primary language (English)
- Exhibit a detail-oriented etiquette and friendly attitude when answering telephone calls.
- Ensure that calls are appropriately escalated to supervisor when necessary
- Ensure timely completion of internal/external training as and when assigned
- Participate/Support in Audits and responsible for closing CAPAs on time
- Provide support in other MICC related activities as per the business requirement.
- Assist in audit/inspection preparation and participation.
Technical Skill Requirements
- Ability to manage multiple stakeholders
- Strong written and verbal communication skills for effective client communication and coordination
Qualification
- Postgraduate or graduate in pharmacy or dentistry is preferred.
- Degree in Life Science/Pharma with 3 to 5 years’ experience in PV
- Minimum 2+ years’ experience in drug safety as part of the Medical Information Call Centre Team.
Seniority level : Associate
Employment type : Full-time
Job function : Customer Service
Industries : Hospitals and Health Care and Pharmaceutical Manufacturing
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