Boehringer Ingelheim (BI) is a leading global pharmaceutical company founded in 1885 and family-owned ever since. With a long-term perspective and a commitment to improving the lives of both humans and animals, BI is powered by over 52,000 employees globally. The company fosters a diverse, collaborative, and inclusive culture, encouraging innovation and personal growth. BI offers challenging and respectful work environments, focusing on employee development and creating breakthrough therapies to benefit patients worldwide.
Responsibilities in Job
The Local Patients Safety Executive plays a pivotal role in ensuring the establishment and maintenance of a local pharmacovigilance (PV) system in India to uphold patient and clinical trial subject safety. Key responsibilities include:
- Case Management:
- Independent execution of Individual Case Safety Report (ICSR) processing, ensuring compliance with local regulations and BI internal processes.
- Classification, local review, and intake of patient safety-relevant information into the Global Safety Platform.
- High-quality translation of local-language cases and coordination with external vendors when required.
- Regulatory Compliance:
- Timely ICSR submissions to local health authorities and ethics committees.
- Maintenance of Local Tradenames (LTNs) and Preferred Product Descriptions (PPDs).
- Screening of local scientific literature for PV-relevant information.
- Collaboration and Process Improvement:
- Conducting reconciliation processes with concerned interfaces.
- Supporting local and global pharmacovigilance audits and inspections.
- Assisting in the implementation of Risk Management Plan (RMP) commitments.
- Training and Awareness:
- Supporting pharmacovigilance training, including translating global training materials into local languages.
- Promoting PV compliance culture and awareness at the local level.
Qualification Requirements
- A healthcare professional qualification such as a physician or pharmacist, or an equivalent qualification with substantial pharmacovigilance experience.
- Proficiency in safety databases like ArisG/LSMV.
- Sound knowledge of processing PV reports within a regulatory framework.
- Strong command of English, both written and spoken.
Desired Skills
- Problem-solving and multi-tasking abilities.
- High attention to detail and the capability to prioritize workloads under stress.
- Proactive approach to process improvement and compliance.
- Strong interpersonal and communication skills to liaise with internal and external stakeholders effectively.
