Assistant Manager Medical Information

APCER Life Sciences, Inc.; India; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

APCER Life Sciences India Ltd is seeking an experienced leader to oversee Medical Information activities from India, coordinating with US MI group and offshore centers. You will hire, mentor, and guide the team; drive training on SOPs, adverse events, and product quality reporting; ensure compliance with regulatory and pharmacovigilance standards while maintaining process excellence.

Responsibilities include auditing, client communications, and ongoing team development to deliver high-quality MI

Qualifications

• Experience leading Medical Information teams.
• Knowledge of regulatory, pharmacovigilance and quality systems.
• Ability to design/train on SOPs and adverse event reporting.
• Experience with audits and CAPA processes.
• Strong focus on process excellence and customer experience.

Responsibilities

• Oversee client-related MI activities from India using dedicated/shared/hybrid model.
• Conduct interviews and mentor new MI team members.
• Provide ongoing feedback, coaching, and performance reviews.
• Design and conduct training on SOPs, adverse events, and product quality reporting.
• Prioritize work to meet timelines and deliverables.
• Ensure regulatory, legal, and pharmacovigilance compliance; perform quality audits.

Skills

Team leadership

Regulatory compliance

SOP training

Quality audits

Process improvement

Documentation

Job description

APCER Life Sciences India Ltd | Full time

• Industry Pharma/Biotech/Clinical Research

Job Description

Oversight on all the client related activities for the MI clients being handled out of India through dedicated/shared/hybrid model.

• Create a collaborative work culture locally and between MI group in US and other offshore centers as may be the case in future.
• Conduct interviews for hiring new team members within MI team and mentoring new resources for the process as and when required.
• Provide ongoing assessment, feedback, and review to the team for targets, call monitoring, and written communications.
• Design and conduct training for the Medical Information team on SOPs and adverse events and product quality complaint reporting.
• Prioritize work based on expected or agreed timelines. Make day to day decisions to achieve the expected outcome for deliverables.
• Ensure adherence to regulatory, legal, and pharmacovigilance requirements for MI. Perform periodic quality audits, in addition to ad hoc checks.
• Team Engagement, Development and Retention: Conduct regular 1: 1 session, flag possible attritions, and develop plan in discussion with HR and senior leadership.
• Identifying gaps, developing process framework, suggest business improvement opportunities and re engineering of the process. Identify & drive opportunities to enhance Customer Experience
• Support the creation and review of SOPs.
• Assist team members to respond to inquiries and complaints received from HCPs, pharmacies, distributors, consumers, and sales representatives; investigates / documents the questions & answers on the appropriate forms/database.
• Determines if inquiries should be further investigated as complaints or adverse event and investigate or triage as per Drug Safety / Quality Assurance Protocols accordingly.
• Respond to escalated inquiries and complaints received from physicians, pharmacies, consumers, and sales representatives; investigates I document the questions & answers on the appropriate forms database.
• Process Excellence: Continuous and ongoing improvement plans within the process and team, identifying opportunities and developing plans for process improvement and excellence.
• Organizes and maintains compliance for client specific documents and folders.
• Contacts internal resources or clients to solicit information required for high level detail to provide accurate answers to product related inquiries.
• Support the medical information department in updating and creating standard response letters, FAQs, product information and other related documents in APCER or client specific database to ensure current and accurate information is being disseminated.
• Plans, coordinates, and conducts training programs for APCER internal departments and new hires. Training may be related to disease, product, systems, or process/compliance.
• Builds and maintains good relationships across functional units and company affiliate Timely sharing of detailed and accurate Productivity and Quality reports.
• Ensuring timely submissions of Monthly billing and all the reconciliation reports etc.
• Ensure timely preparation of Monthly and Quarterly client review decks.
• Design and conduct training for the Medical Information team on SOPs and adverse events and product quality complaint reporting.
• Prepare for and support Internal, Client, Third Party, and Regulatory Authorities audits and inspections.
• Support MI leadership in preparing for and meeting with potential clients.
• Ensure that CSV related deliverables for all the MI enablers including contact center solution, MI database are met, and any changes do not impact the validated states of these systems.
• Ensure that all the RFIs and RFPs are completed for MI related information/data and is submitted to TPS team in a timely manner.
• Ensure timely submission of the audit responses for internal/external audits and/or inspections along with appropriate and practically implementable CAPAs.
• Review and update the LE sheets on monthly basis along with the MI functional CP and inform MI management of any significant deviations from the budgeted volumes.
• Monitor the business continuity and alert the leadership of any situation which may interrupt the continuity.
• Ensure appropriate preparation of MI team if BCP is implemented. Coordinate with other departments within APCER to ensure MI team members have all required resources if they must work under restricted conditions during BCP.
• Act as Point of contact for all the other departments of APCER and coordinate with them to provide required MI related information.
• Timely review and closure of performance management cycle for MI team members.
• Identification of team’s requirement for any additional training/learning program and inform the same to MI leadership for evaluation of feasibility of such a program.