Patient Safety Executive

0-1 years

Not Disclosed

Freiburg Kuala Lumpur

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: Local Pharmacovigilance (PV) Specialist
Company: Boehringer Ingelheim
Location: Malaysia, Singapore, Brunei (Support for Indonesia as applicable)

Role Summary

This position plays a vital role in maintaining the local Pharmacovigilance (PV) system, ensuring the safety of patients and clinical trial subjects while safeguarding public health. The PV Specialist will independently handle the processing of Individual Case Safety Reports (ICSRs) with a high standard of quality, adhering to both local regulatory requirements and Boehringer Ingelheim’s internal processes.

The role involves collaborative work with internal teams and proactive support for PV-related queries across Malaysia, Singapore, Brunei, and Indonesia.

Key Responsibilities

Compliance

Perform local management of PV-relevant information, including ICSR intake, processing, follow-up, reconciliation, documentation, and archiving.
Execute timely ICSR submissions to local health authorities and ethics committees in compliance with regulatory standards.
Translate case information into local languages or coordinate external translations for complex cases.
Ensure adherence to data protection standards by redacting personal information from source data.
Draft concise and understandable follow-up queries targeting missing information.

Quality Management

Support Pharmacovigilance training by adapting global training materials to local languages.
Conduct screenings of Boehringer Ingelheim websites and CRM systems for PV-relevant information.
Perform "Out of Office" test calls to ensure 24-hour PV availability through internal interfaces and external vendors.
Participate in local inspections, audits, and PV-related activities.
Monitor local scientific literature for PV-relevant data.

Archiving

Archive all PV-related documents promptly, adhering to Boehringer Ingelheim’s standards and regulatory requirements.
Independently perform archive retrieval checks and ensure proper documentation.

Collaboration and Contribution

Foster a culture of PV compliance and awareness across local organizations in line with global initiatives.
Actively participate in the preparation and execution of PV audits and inspections.

Professional Development

Complete assigned learning modules via the Learning One Source (LOS) platform on time.

Requirements

Bachelor’s degree in Life Sciences (required); PV experience is advantageous.
Strong multitasking abilities in a fast-paced, diverse environment.
Goal-oriented and innovative mindset with a passion for continuous learning.
Proficiency in English and excellent communication skills.

Why Join Boehringer Ingelheim?

At Boehringer Ingelheim, we’re driven by a commitment to improve lives—both human and animal. Since our founding in 1885, we have remained family-owned, fostering a culture that values innovation, collaboration, and long-term vision. With over 52,000 employees globally, our environment is diverse, inclusive, and ripe with opportunities for growth.

What We Offer:

A challenging and meaningful career in a collaborative global workplace.
Continuous learning and professional development opportunities.
A commitment to diversity, equity, and inclusion, making every voice heard and valued.

Equal Opportunity Employer
Boehringer Ingelheim proudly embraces diversity in all forms, fostering an inclusive workplace that benefits employees, patients, and the community.

Learn more about our work at Boehringer Ingelheim Careers.

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