Local Patients Safety Lead - Mumbai

Boehringer Ingelheim; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

A leading pharmaceutical company seeks a dedicated professional to lead the India Patient Safety & Pharmacovigilance team. This senior role involves developing local strategies, ensuring compliance with regulations, and fostering a culture of patient safety through effective stakeholder engagement and team leadership.

Qualifications

• 8-10 years of Pharmacovigilance experience preferred in healthcare.
• Excellent knowledge of PV regulations and GxP requirements.
• Ability to manage a diverse team under stress.

Responsibilities

• Define and implement local PSPV strategy with patient safety goals.
• Manage local Pharmacovigilance Agreements and collaborate with global teams.
• Network with stakeholders on PV topics to enhance the pharmacovigilance landscape.

Skills

Leadership

Strategic thinking

Regulatory knowledge

Technical expertise

Education

Degree in Medicine

Tools

PV databases

Job description

The Position

Lead and develop the India Patient Safety & Pharmacovigilance (LPV) Team and define the local PSPV strategy based on the framework provided by global PSPV. Ensure the establishment and maintenance of a local pharmacovigilance (PV) system to safeguard patient and clinical trial subject safety and public health in India, in compliance with regulatory requirements and internal procedures. Act as the local PV contact person for the national Health Authority.

Tasks & Responsibilities

1. Define the Local PSPV strategy with patient safety as the ultimate goal, including local product activities/initiatives.
2. Advocate for the Patient Safety & Pharmacovigilance strategy within BI.
3. Develop and implement activities to enhance PSPV culture and awareness aligned with global recommendations.
4. Understand pharma market dynamics and BI internal needs and strategies.
5. Network with external stakeholders on PV topics and contribute to the pharmacovigilance landscape.
6. Lead and develop the local PSPV team, embodying BI's culture and principles.
7. Drive the implementation of changes and project execution efficiently.
8. Assess local PSPV resource needs and ensure adequate coverage, including deputy preparedness.
9. Initiate and support patient-oriented activities to improve safety practices.
10. Establish and maintain a compliant local PV system, including documentation and frameworks.
11. Manage local Pharmacovigilance Agreements in collaboration with Global Partner Management and legal teams.
12. Inform and involve Medical and HPBU leadership on patient safety topics.
13. Manage the local PSPV budget within defined margins.

Requirements

• Major focus in Medicine or proven experience in Patient Safety & Pharmacovigilance.
• Excellent knowledge of PV regulations, BI processes, and GxP requirements.
• Act as a contact for the local Health Authority on PV matters.
• 8-10 years of Pharmacovigilance experience, preferably in healthcare or related fields.
• Leadership skills to manage a diverse team, including under stress.
• Knowledge of BI therapeutic areas and drug development process.
• Technical expertise in PV databases and GxP regulations.
• Goal-oriented, strategic thinker, innovative, continuous learner.
• Position based in Mumbai.

Application Instructions

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About Boehringer Ingelheim

We develop breakthrough therapies to improve lives, with a long-term perspective and a diverse, inclusive culture. Join us to grow, innovate, and make an impact.

Visit https://www.boehringer-ingelheim.com for more information.