Deputy Manager

Lambda Therapeutic Research

5+ years

Not Disclosed

Ahmedabad

10 Dec. 19, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Deputy Manager
Location: Ahmedabad, India
Company: Lambda Therapeutic Research Ltd.
Date: Dec 11, 2024

Organizational Overview

Lambda Therapeutic Research Ltd. is a leading global Clinical Research Organization (CRO) providing comprehensive services to the biopharmaceutical and generic industries. With over 20 years of experience, Lambda operates in several locations worldwide, offering cutting-edge clinical trial solutions to help clients develop products safely, efficiently, and with a commitment to quality.

Job Details

The Deputy Manager in the Pharmacovigilance Department is responsible for providing expert pharmacovigilance guidance to both clients and colleagues, ensuring that all activities are performed in line with regulatory requirements, internal SOPs, and industry guidelines. This role also involves leading and supporting the pharmacovigilance team, overseeing medical assessments of adverse events, and contributing to the ongoing improvement of safety processes.

Key Responsibilities

Pharmacovigilance Support: Provide expert pharmacovigilance advice and ensure compliance with SOPs, regulations, and guidelines.
Medical Leadership: Lead the medical assessment of adverse events, evaluate causality, and participate in the follow-up of safety issues related to clients' products.
Team Support & Management: Mentor and support the pharmacovigilance team, train new team members, and ensure proper work allocation and task management for compliance.
Regulatory Intelligence: Stay informed on changes to local and national pharmacovigilance regulations and ensure they are implemented effectively.
Quality Assurance: Conduct thorough evaluations of adverse events, review data entry, drug coding, and MedDRA coding, ensuring adherence to internal SOPs and external regulatory standards.
Continuous Improvement: Contribute to the development of SOPs and process enhancements to improve pharmacovigilance operations and ensure timely submission of ICSR reports.
Client Communication: Provide high-quality communication with clients and regulatory authorities regarding safety issues, inquiries, and safety responses.
Training and Development: Ensure proper training for new team members and provide ongoing development for the pharmacovigilance team.

Key Deliverables

Ensuring compliance with pharmacovigilance regulations and company standards
Accurate and timely assessment of adverse events and causality
Effective management of pharmacovigilance team and task allocation
Support for regulatory submissions and safety responses
Training and mentoring of new team members

Allied Responsibilities

Contribute to the continuous improvement of pharmacovigilance processes
Ensure high standards in communication with all internal and external stakeholders
Support the timely and accurate submission of reports to regulatory authorities

Experience

Minimum 5+ years in pharmacovigilance with prior team handling experience.

Educational Qualifications

MBBS / MD in Pharmacology or related fields.

Competencies

Accountability and strong work ethic
Effective communication and leadership skills
Initiative in planning and organizing tasks
Ability to foster team motivation/initiative
High technical knowledge in pharmacovigilance
Strong interpersonal and presentation skills

Why Join Us?

Lambda Therapeutic Research is a place where you can make a tangible impact on the world of clinical trials. If you are passionate about pharmacovigilance, have the expertise in managing teams, and want to contribute to the safety and compliance of clinical products, join us to work alongside experienced professionals and grow in a supportive and dynamic environment.

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Deputy Manager

Job Description

Organizational Overview

Job Details

Key Responsibilities

Key Deliverables

Allied Responsibilities

Experience

Educational Qualifications

Competencies

Why Join Us?

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