Job Title:  Senior Officer-Global Medical Information

ORGANISATIONAL OVERVIEW

At Lambda Therapeutics, we provide end-to-end pharmacovigilance solutions tailored for a variety of products, including generics, combination products, vaccines, and medical devices. Our extensive experience encompasses all phases of drug safety monitoring, ensuring compliance with regulatory standards throughout the entire lifecycle of medicinal products.

Key Highlights of Our Pharmacovigilance Services:

• Global Expertise: With a dedicated team of over 160 professionals, including physicians and pharmacovigilance specialists, we have successfully supported more than 265 clinical trials across diverse therapeutic areas.
• Robust Framework: Our well-established pharmacovigilance framework guarantees thorough safety monitoring and adherence to regulatory requirements, empowering drug safety and enhancing patient well-being.
• Advanced Technology: We utilize an automated web-based pharmacovigilance solution compliant with international standards, which streamlines processes and ensures accuracy in data handling.

JOB DETAILS

1. Daily Checks: Ensure that the medical inquiry email box, phone, and postal mail are checked daily for adverse events, medical inquiries, and product inquiries.
2. Call Handling Support: Provide dedicated support for handling incoming medical information calls across EU, UK, USA, and other applicable global regions. Ensure accurate documentation, triage, and escalation of inquiries received via phone.
3. Tracking and Handling: Manage medical inquiries in accordance with the company’s controlled documents (e.g., SOPs, WIs, Guides).
4. Database Management: Log and update inquiries in the Medical Information database.
5. Safety ID Creation: Create Safety IDs in the global safety database.
6. Support Medical Reviewers: Assist designated medical reviewers with follow-ups on all medical inquiries and communicate responses in coordination with them.
7. Reconciliation of Inquiries: Reconcile medical inquiries received from clients, affiliates, and business partners.
8. Acknowledgment of Events: Reconcile and acknowledge adverse events/product complaints emails as per Safety Data Exchange Agreement (SDEA) and Product Management Plan (PMP).
9. Documentation Preparation: Prepare SDEA, SOPs, and Work Instructions (WIs).
10. Additional Responsibilities: Perform additional tasks as assigned by the Team Lead or Manager.
11. Audit Support: Assist in preparing for audits/inspections and participate when appropriate.
12. Response Communication: Prepare and communicate inquiry responses in coordination with designated medical reviewers.

KEY DELIVERABLES

ALLIED RESPONSIBILITIES

EXPERIENCE

Candidates given priority if they have 01 Year of MICC Experience or Excellent communication skills in English

EDUCATIONAL QUALIFICATION

B. Pharm, M. Pharm, Pharm D (Any, Preferably in Pharmacology).

COMPETENCIES