Job Information
Boehringer Ingelheim Local Patients Safety Lead - Mumbai in Mumbai, India
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.
Ensures the establishment and maintenance of a local pharmacovigilance (PV) system to safeguard patient's and clinical trial subject’s safety and public health in India in compliance with regulatory requirements and applicable internal procedures and processes.
Ensures compliance with external requirements in line with the local PV legislation and applicable internal procedures and processes allowing the company to obtain and maintain marketing authorization of its products.
Acts as local PV contact person for the national Health Authority.
Tasks & Responsibilities
Defines the Local PSPV strategy with patient safety as ultimate goal, including defining the local product activities/initiatives.
Advocates the Patient Safety & Pharmacovigilance strategy to interfaces within BI.
Develops and implements together with local PSPV team and concerned other functions activities to enhance PSPV culture and PSPV awareness in line with global recommendations.
Understands the pharma market dynamics, trends as well as BI internal needs and strategy.
Actively networks with external stakeholders to exchange on new and emerging topics related to PV and contributes, where applicable/possible, to impact the pharmacovigilance landscape.
Leads and develops the local PSPV team by living the AAI principles, the BI culture and One Medicine strategy.
Demonstrates personal accountability and integrity while setting and communicating expectations and using the diversity of team members to exceed business needs.
Drives fast and complete implementation of changes/execution of projects.
Assesses continuously local PSPV resource needs in collaboration with ROPU PS Head and the local Medical Director (e.g., deputy coverage);
Ensuring Deputy LPSL (Deputy LQPPV, if applicable) has adequate preparedness and handover to take over LPSL responsibilities, whenever LPSL is absent.
Initiates, evaluates, implements and supports activities that are patient oriented and improve the status quo.
Fosters innovation by brainstorming together with BI internal and external partners/stakeholders on new approaches and challenging the status quo for new products, services or collaborations.
Establishes and maintains a local PV system compliant with applicable regulations and BI processes. Ensures that the local PV system is adequately described in the Local PV System Framework and applicable local documents (e.g., PV Repository, How to Guides).
Fulfills the responsibilities of the Local PS Lead as described in BI Global, [Regional/ROPU] and Local Processes.
Manages local Pharmacovigilance Agreements (PVAs) in cooperation with Global Partner Management and provides adequate localized PV clauses/language to the Legal/Purchasing Department as well as guidance for implementation and support for individual contracts.
Adequately informs and involves the Medical and HPBU leadership team about patient safety relevant topics.
Manages the local PSPV budget within the defined margins.
Requirements
Education: Major focus in Medicine and/or proven experience in Patient Safety & Pharmacovigilance.
Excellent knowledge of applicable global, regional and local PV regulations, BI processes, relevant GxP requirements and patient safety relevant topics.
Acting as a contact person for the Local Health Authority for pharmacovigilance aspects.
This is a highly demanding role requiring strategic, patient-centric thinking, comprehensive expertise in pharmaceutical development processes, balanced risk-based decision making, ability to organize PV tasks efficiently.
8-10 years of Pharmacovigilance experience
Health care professional e.g., physician, pharmacist or an appropriately qualified person with considerable Pharmacovigilance experience.
Comprehensive functional and technical skills in PV; demonstrates the capability of transferring the knowledge into practice, and ability to transfer previous experience in the BI environment.
Excellent leadership skills to manage a diverse team including in stressful situations.
Working knowledge of BI therapeutic areas and the drug development process.
Good technical knowledge of Pharmacovigilance databases.
Sound expertise in GxP regulations.
Demonstrated ability to be goal orientated, a strategic thinker, innovative/creative and the desire to constantly learn.
Excellent leadership, communication, management and coaching skills.
position will be based at Mumbai.
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HR Direct contact information:
Phone: +91-22-7145-6700
Email: HRDirect.PH@boehringer-ingelheim.com
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.