Lambda Therapeutic Research is a renowned global provider of integrated services to the pharmaceutical and biotechnology industries. With a commitment to excellence in clinical trials and pharmacovigilance, Lambda supports the development and approval of new drugs and therapies. The company focuses on ensuring patient safety and compliance with regulatory requirements, making it a leader in providing high-quality services within the healthcare industry.
Job Overview
The Officer – Pharmacovigilance role at Lambda Therapeutic Research in Ahmedabad is an exciting opportunity for individuals with a background in MPharm or Pharm D. The position is ideal for candidates with 0 to 2 years of experience who are passionate about contributing to the safety and efficacy of medical products through pharmacovigilance processes.
Key Responsibilities
Literature Screening
- Reviewing worldwide scientific and medical literature in line with SOPs, WIs, and relevant regulations.
- Documenting safety reports and maintaining organized records.
- Communication of urgent safety issues to the Line Manager.
- Supporting case processing, including data entry, drug coding, MedDRA coding, listedness, causality assessment, narrative writing, and regulatory compliance.
- Managing regulatory cases and performing tasks like creating safety IDs and duplicate searches.
- Preparing and revising SOPs, WIs, templates, guides, and training documents.
Basic Entry Responsibilities
- Data entry of regulatory cases and creating safety IDs from received files.
- Tracking regulatory cases and performing weekly reconciliations.
- Supporting compliance with local regulations and global pharmacovigilance requirements.
Medical Information and Customer Communication (MICC)
- Handling medical inquiries related to adverse events, product inquiries, and complaints.
- Updating medical information databases and creating safety IDs in global safety databases.
- Reconciliation of medical inquiries from clients, affiliates, and business partners.
- Participating in audits/inspections when required and assisting with the preparation of related documentation.
Qualifications and Skills
Required Qualifications
- Educational Qualification: M.Pharm or Pharm D.
- Experience: 0 to 2 years of experience in pharmacovigilance or related fields.
Key Skills
- Attention to Detail: The ability to work with precision in managing safety data and regulatory cases.
- Strong Communication: Excellent verbal and written communication skills for effective interactions with team members and clients.
- Organizational Skills: Ability to maintain organized records and manage multiple tasks efficiently.
- Knowledge of Regulations: Understanding of pharmacovigilance regulations and guidelines like SDEA, SOPs, and WIs.
- Problem-Solving Ability: Capacity to independently resolve issues related to case processing and reporting.
Lambda Therapeutic Research is a renowned global provider of integrated services to the pharmaceutical and biotechnology industries. With a commitment to excellence in clinical trials and pharmacovigilance, Lambda supports the development and approval of new drugs and therapies. The company focuses on ensuring patient safety and compliance with regulatory requirements, making it a leader in providing high-quality services within the healthcare industry.
Job Overview
The Officer – Pharmacovigilance role at Lambda Therapeutic Research in Ahmedabad is an exciting opportunity for individuals with a background in MPharm or Pharm D. The position is ideal for candidates with 0 to 2 years of experience who are passionate about contributing to the safety and efficacy of medical products through pharmacovigilance processes.
Key Responsibilities
Literature Screening
- Reviewing worldwide scientific and medical literature in line with SOPs, WIs, and relevant regulations.
- Documenting safety reports and maintaining organized records.
- Communication of urgent safety issues to the Line Manager.
- Supporting case processing, including data entry, drug coding, MedDRA coding, listedness, causality assessment, narrative writing, and regulatory compliance.
- Managing regulatory cases and performing tasks like creating safety IDs and duplicate searches.
- Preparing and revising SOPs, WIs, templates, guides, and training documents.
Basic Entry Responsibilities
- Data entry of regulatory cases and creating safety IDs from received files.
- Tracking regulatory cases and performing weekly reconciliations.
- Supporting compliance with local regulations and global pharmacovigilance requirements.
Medical Information and Customer Communication (MICC)
- Handling medical inquiries related to adverse events, product inquiries, and complaints.
- Updating medical information databases and creating safety IDs in global safety databases.
- Reconciliation of medical inquiries from clients, affiliates, and business partners.
- Participating in audits/inspections when required and assisting with the preparation of related documentation.
Qualifications and Skills
Required Qualifications
- Educational Qualification: M.Pharm or Pharm D.
- Experience: 0 to 2 years of experience in pharmacovigilance or related fields.
Key Skills
- Attention to Detail: The ability to work with precision in managing safety data and regulatory cases.
- Strong Communication: Excellent verbal and written communication skills for effective interactions with team members and clients.
- Organizational Skills: Ability to maintain organized records and manage multiple tasks efficiently.
- Knowledge of Regulations: Understanding of pharmacovigilance regulations and guidelines like SDEA, SOPs, and WIs.
- Problem-Solving Ability: Capacity to independently resolve issues related to case processing and reporting.
