Boehringer Ingelheim (BI) is a global leader in the pharmaceutical industry, committed to developing breakthrough therapies for both human and animal health. Founded in 1885 and family-owned ever since, the company now employs over 52,000 individuals worldwide. BI thrives on fostering a diverse, inclusive, and innovative work culture. Their mission focuses on improving lives through cutting-edge research and solutions.
Responsibilities in the Role
As a Local Patients Safety Executive, you will play a critical role in maintaining a robust local pharmacovigilance (PV) system in India. Your contributions ensure patient safety, clinical trial subject protection, and compliance with regulatory standards. Key responsibilities include:
- ICSR Processing: Independently manage Individual Case Safety Reports, including classification, local review, follow-up, documentation, and submission to local health authorities.
- Data Translation & Redaction: Provide accurate translations of cases and ensure compliance with data protection requirements.
- Reconciliation and Screening: Perform reconciliations with internal interfaces, screen CRM and scientific literature for PV-relevant data.
- PV System Support: Assist in the creation and optimization of local PV processes and documentation, such as SOPs and local frameworks.
- Training & Awareness: Support pharmacovigilance training, ensuring PV compliance culture within the organization.
- Audit Readiness: Prepare for inspections and audits, providing necessary documentation and support.
Qualifications and Skills
To excel in this role, candidates should meet the following criteria:
Educational Requirements
- A healthcare professional background (e.g., physician, pharmacist) or significant pharmacovigilance experience.
- Proficiency in safety databases like ArisG and LSMV is mandatory.
Skills and Competencies
- Strong knowledge of PV processes and regulatory contexts.
- Excellent written and verbal communication in English.
- Problem-solving and multitasking capabilities under pressure.
- Ability to prioritize workloads, maintain attention to detail, and deliver results.
- Proficiency in data reconciliation and global safety platform usage.
For technical issues, contact HR Direct at:
- Phone: +91-22-7145-6700
- Email: HRDirect.PH@boehringer-ingelheim.com
