Lambda Therapeutic Research Ltd., a renowned global organization, invites talented professionals to join their team in Ahmedabad, India. With an established legacy in delivering end-to-end pharmacovigilance solutions, Lambda is committed to ensuring patient safety and drug compliance across diverse therapeutic areas. Explore the exciting opportunities as an Officer – Literature Screening and Officer – Medical Information Call Center (MICC).
About Lambda Therapeutic Research Ltd.
Lambda Therapeutic Research Ltd. is a trusted name in pharmacovigilance, offering tailored solutions for generics, combination products, vaccines, and medical devices. With a robust framework and advanced technology, Lambda has successfully supported over 265 clinical trials globally. The organization thrives on innovation, ensuring adherence to international standards and regulatory compliance.
Responsibilities in the Role
Officer – Literature Screening
- Global Literature Review: Conduct thorough reviews of scientific and medical literature per company SOPs and relevant regulations.
- Case Processing Support: Manage data entry, drug coding, MedDRA coding, and ICSR narrative writing.
- Regulatory Case Management: Track and reconcile cases received from regulatory authorities.
- Document Development: Prepare, revise, and review SOPs, WIs, templates, and training materials.
- Urgent Safety Communication: Identify and report urgent safety issues to the Line Manager.
Officer – Medical Information Call Center (MICC)
- Inquiry Management: Manage medical and product inquiries received through various channels.
- Database Updates: Log inquiries and create Safety IDs in the global safety database.
- Communication Coordination: Prepare inquiry responses in collaboration with medical reviewers.
- Reconciliation & Acknowledgment: Handle adverse event and product complaint reconciliation per agreements.
- Documentation Support: Develop SDEA, SOPs, and Work Instructions (WIs).
Required Qualifications
Candidates must hold one of the following qualifications, preferably in Pharmacology:
- B. Pharm
- M. Pharm
- Pharm D
Skills and Competencies
Lambda seeks candidates with the following skills:
- Accountability: Reliable and responsible in all tasks.
- Communication: Strong verbal and written English communication skills.
- Technical Knowledge: Proficiency in pharmacovigilance processes and medical inquiry handling.
- Work Ethic and Initiative: Proactive approach and dedication to achieving excellence.
- Interpersonal Skills: Strong leadership, teamwork, and organizational abilities.
Candidates with a Pharmacovigilance Certification Course (for Literature Screening) or at least one year of MICC experience (for MICC) will be given priority Or If You have Good Communications
Application Link Officer – Literature Screening
Application Link Officer – Medical Information Call Center (MICC)
