Boehringer Ingelheim Pharmacist Job Opening – Apply Online

Boehringer Ingelheim Pharmacist Job Opening – Apply Online

Local Patients Safety Executive – Mumbai

JOB ID: 16763

The Position

Team contribution to ensure the establishment and maintenance of a local pharmacovigilance (PV) system to support patient and clinical trial subject safety and public health in India. Self-dependent execution of Individual Case Safety Report (ICSR) processing in high quality and in line with local regulatory requirements and BI internal processes. The Patient Safety & Pharmacovigilance Associate ensures that all delegated operative tasks of the local BI Pharmacovigilance System are prioritized, performed in a timely manner, and regularly checked according to current BI processes. Close cooperation with BI-internal interfaces and proactive support for people contacting PV in India with regards to pharmacovigilance-related matters.

Tasks & Responsibilities

• Self-dependent execution and team contribution for management of PV-relevant information received locally, including:
  • ICSR collection, local processing, follow-up, reconciliation, documentation, and archiving.
  • PV reporting to local Health Authorities/Ethics Committees in line with applicable regulations and respective BI processes.
• Intake, case classification, and local review of patient safety-relevant information in the Global Safety Platform.
• Provide high-quality translation of case information in the local language or coordinate translation with external vendors, where applicable.
• Ensure personal information is redacted
  from source data in line with data protection requirements.
• Send follow-up queries concerning case information within BI timelines and document them properly in the Global Safety Platform.
  • Ensure queries are easy to understand for external customers and targeted to the missing information.
• Perform ICSR submission to local Health Authorities and/or Ethics Committees/Institutional Review Boards (IRB) in line with BI processes and regulatory requirements.
• Provide feedback to LPSL regarding any discovered findings to enhance the ICSR processing process.

Additional Responsibilities:

• Contribute to the quality of the local PV system by executing tasks in line with BI processes and timelines, such as:
  • Perform reconciliations with all concerned interfaces (e.g., Medical Affairs, Technical Product Complaints, Customer Service Center, Market Access, PV Vendors, License Partners).
  • Support pharmacovigilance training, including translating global training material into the local language.
  • Conduct website screening/tests for PV-relevant information reporting accuracy.
  • Conduct CRM screening for patient safety-relevant information.
  • Perform Out of Office (OoO) test calls by BI internal interfaces and external vendors contributing to 24-hour availability.
  • Screen local scientific literature for PV-relevant information.
  • Maintain local tradenames (LTNs) and preferred product descriptions (PPDs).
  • Support local pharmacovigilance agreements (PVAs) under LPSL’s guidance in cooperation with Global Partner Management.
  • Support local colleagues with PV process-related questions related to IIS/NIS/local studies.
• Archive all relevant documents in a timely manner per BI processes and regulatory requirements, including:
  • Perform archive retrieval checks independently and document them.
• Assist with the implementation of RMP commitments in cooperation with the global PVWG and relevant local functions.
• Enhance PV compliance culture and PV awareness at the local organizational level in line with global recommendations.
• Support local inspection/audit readiness and participate in PV audits and inspections as requested.
• Assist the LPSL in setting up/optimizing local PV processes, including tasks like creating/revising related documentation (SOPs, Local PV System Framework, KMed Assets, etc.).
• Complete assigned Learning One Source (LOS) curricula on time.

Requirements

• Education: Health care professional (e.g., physician, pharmacist) or an appropriately qualified person with considerable pharmacovigilance experience.
• Knowledge of safety databases (ArisG/LSMV mandatory).
• Sound knowledge of operative processing of PV-reports in the regulatory context.
• Good command of English in writing and speaking.
• Problem-solving and multitasking skills.
• Ability to prioritize workload and perform under stress, particularly when working speed and sustained attention are critical.
• Result-oriented and capable of proposing alternatives for process improvements.