Instagram
youtube
Facebook

Local Patients Safety Executive - Mumbai

2+ years
Not Disclosed
10 Dec. 6, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Position: Patient Safety & Pharmacovigilance Associate
Company: Boehringer Ingelheim
Location: India
Employment Type: Full-Time


Position Overview

As a Patient Safety & Pharmacovigilance Associate, you will play a critical role in establishing and maintaining a local pharmacovigilance (PV) system to ensure the safety of patients and clinical trial subjects in India. The role requires self-driven execution of Individual Case Safety Report (ICSR) processing in compliance with local regulatory standards and Boehringer Ingelheim (BI) processes. You will support cross-functional teams, manage PV-related tasks, and contribute to enhancing PV compliance culture at the local level.


Key Responsibilities

Pharmacovigilance Operations

  • Manage PV-relevant information, including ICSR collection, processing, follow-ups, reconciliation, documentation, and archiving.
  • Ensure timely ICSR submission to local Health Authorities and Ethics Committees as per BI processes and regulatory requirements.
  • Translate complex local language case data and ensure personal data protection compliance.
  • Conduct local scientific literature screening for PV-relevant information.
  • Manage reconciliation processes with internal and external interfaces (e.g., Medical Affairs, Customer Service).

System Maintenance and Compliance

  • Conduct CRM and BI website screenings to identify PV-relevant data.
  • Perform out-of-office test calls to ensure 24/7 availability compliance.
  • Maintain local trade names (LTNs) and preferred product descriptions (PPDs).
  • Archive documents in compliance with BI processes and regulatory standards.

Training and Collaboration

  • Translate global PV training materials into the local language and deliver training.
  • Provide guidance on PV processes related to local and global studies.
  • Collaborate with cross-functional colleagues and global teams to ensure compliance with Risk Management Plan (RMP) commitments.

Inspection and Process Enhancement

  • Support local audits and inspections, including readiness activities.
  • Assist in creating and revising Standard Operating Procedures (SOPs) and PV system documentation.
  • Propose and implement process improvements to enhance efficiency and compliance.

Required Qualifications

  • Education: Healthcare professional (e.g., physician, pharmacist) or a qualified individual with significant pharmacovigilance experience.
  • Proficiency in safety databases (ArisG/LSMV mandatory).
  • In-depth knowledge of PV report processing in a regulatory context.
  • Strong command of written and spoken English.

Skills and Competencies

  • Exceptional problem-solving and multitasking abilities.
  • Ability to prioritize tasks under time constraints while maintaining attention to detail.
  • Result-oriented mindset with the ability to suggest process improvements.

Why Join Boehringer Ingelheim?

Boehringer Ingelheim is a global, family-owned organization driven by innovation and dedicated to improving lives. With over 52,000 employees worldwide, the company fosters a collaborative, inclusive, and growth-oriented work environment. Employees benefit from:

  • A culture of respect and innovation.
  • Opportunities for personal and professional growth through learning and development.
  • Commitment to diversity and inclusion.

Application Process

  1. Click “Apply On Company Website.”
  2. Create an account or sign in to register your profile, upload your resume, and apply.

For technical issues, contact HR Direct:


Equal Opportunity Employer
Boehringer Ingelheim is an equal-opportunity employer committed to maintaining a diverse and inclusive environment. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, or veteran status.

To learn more, visit: Boehringer Ingelheim Careers.