Assistant General Manager

ORGANISATIONAL OVERVIEW

KEY DELIVERABLES

• To ensure proper work allocation to all team members to ensure compliance and whenever required, training and assessment of a new team member before independent task allocations into the production system
• Acting as line manager for medical reviewer team and strategic work distribution and management of team
• Responsibility for evaluation of Adverse Events and provide causality. Review of data entry, Drug coding, MedDRA coding and listedness. Assessment for expediting and narrative review of ICSR in accordance with Company’s controlled documents (e.g. SOPs, WIs, Guide) relevant regulations and guidelines
• Medical inputs for identification of ICSR from Literature and spontaneous source. Provide guidance to team for identification of article of special interest from literature source. 
• To ensure the provision of appropriate pharmacovigilance advice to clients and colleagues.
• To ensure pharmacovigilance activities within Lambda are carried out in accordance with all SOPs, relevant regulations, and guidelines.
• To provide support and medical leadership for the assessment of all pharmacovigilance activities throughout the department.
• Assist in the development of appropriate Standard Operating Procedures for the Lambda Pharmacovigilance Department and clients.
• To provide support to other members of the pharmacovigilance team as required.
• To support and assist less experienced team members to enable them to fulfil their roles
• Regulatory Intelligence: Awareness of changes to and implementation of relevant regulations
• Medical assessment of the safety profile of the client's product range.
• Provide guidance and participation in the follow-up of Adverse Events.
• To set in process for continuous improvement and Providing input into responses to inquiries from regulatory authorities or health care professionals on safety issues.
• Knowledge of local and national requirements for pharmacovigilance requirements and interact with staff at various levels and in various functional areas to resolve any issues that arise during reviews
• Providing input into responses to inquiries from regulatory authorities or health care professionals on safety issues and assist in the training team members.
• Contributing to the on-going enhancement of Pharmacovigilance processes and writing Standard Operating Procedures
• Support for timely submission of ICSR in order to achieve 100% regulatory compliance
• Work with the Aggregate Report/ ICSR team leader to escalate issues or tasks outside the normal scope of work.
• Deliver training to new joinee and team as per requirement and Provide back-up medical support on products/projects where required.
• Ensuring compliance (quality, procedures, regulations, timeliness, consistency) with local regulations and Company’s global Pharmacovigilance requirements.

ALLIED RESPONSIBILITIES

EXPERIENCE

Preferred candidate profile:

> Responsible for following process,

• Medical review of ICSR,
• Medical review of Literature process (validation of ICSR, AOI)
• Medical review of medical information activity

> 12 + yrs. experience in Medical Reviewer & Signal detection is required.

> Should have 5+ yrs team handling experience.

EDUCATIONAL QUALIFICATION

> Education: MBBS/MD/BHMS/BAMS/BDS with experience.

COMPETENCIES