If you’re a healthcare professional passionate about pharmacovigilance and patient safety, Boehringer Ingelheim offers an exciting opportunity in Mumbai. As a globally recognized company dedicated to improving lives through breakthrough therapies, this role is pivotal in ensuring compliance with local pharmacovigilance systems and safeguarding patient health.
About Boehringer Ingelheim
Founded in 1885, Boehringer Ingelheim is a family-owned pharmaceutical company with over 52,000 employees worldwide. With a strong commitment to innovation, diversity, and inclusion, the company focuses on developing therapies that make a real difference in the lives of humans and animals. Boehringer Ingelheim fosters a collaborative environment where employees can grow, innovate, and contribute to creating a healthier future.
Key Responsibilities of the Role
As a Local Patients Safety Executive, your contributions will focus on establishing and maintaining a local pharmacovigilance (PV) system. Key tasks include:
- Individual Case Safety Report (ICSR) Processing: Manage the collection, classification, follow-up, and documentation of PV-relevant information locally.
- Regulatory Compliance: Ensure timely submission of ICSRs to local Health Authorities and Ethics Committees in line with regulations.
- Data Protection: Translate and redact patient information in compliance with data protection guidelines.
- Quality Assurance: Conduct reconciliations with internal interfaces, monitor CRM systems, and test for 24-hour availability.
- Support for Audits & Training: Assist in inspections, audits, and pharmacovigilance training programs.
- Literature Screening & Archive Management: Review local scientific literature for PV-relevant information and maintain proper documentation archives.
- Process Enhancement: Collaborate on improving PV systems and creating/revising local SOPs and frameworks.
Qualifications & Skills Required
To succeed in this role, the following qualifications and skills are essential:
- Educational Background: Healthcare professional (e.g., physician, pharmacist) or relevant qualification with significant pharmacovigilance experience.
- Technical Expertise: Proficiency in safety databases (ArisG/LSMV) and operative processing of PV-reports in regulatory contexts.
- Language Skills: Excellent English communication skills (written and spoken).
- Problem-Solving Abilities: Capability to prioritize tasks, multitask, and perform under pressure.
- Attention to Detail: Strong focus on accuracy and process improvements.
