Patient Safety Manager, Thailand

1 week ago


Thailand Boehringer Ingelheim Full time

**Patient Safety Manager, Thailand**
**-**
**232054**

At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective.

Now, we are powered by 52,000 employees globally who nurture a diverse, collaborative and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.

**THE POSITION**
- Develop and define Thailand the Local PS & PV strategy based on the framework provided by global PSPV.
- 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.

**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.
- 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.
- 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.
- 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,
- Responsible for management of PV relevant information received locally (e.g. ICSR collection, local processing, follow-up, reconciliation, documentation and archiving) including PV reporting to local Health Authorities/Ethics Committees in line with applicable external regulations and BI internal processes.
- Ensures appropriate PV training of all BI staff and those working on behalf of BI in the respective territory;
- 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;
- Ensures that an up-to-date Business Contingency Plan is in place;
- Sets-up and organizes/conducts, [if relevant local journals are identified], the local scientific literature screening.
- Maintains oversight/implements Risk Management Measures as applicable, meeting BI internal and regulatory requirements
- Prepares local periodic reports and local RMPs with country-specific format and content if needed in liaison with global PSPV functions.
- Adequately informs and involves the Medical and HPBU leadership team about patient safety relevant topics.
- In addition, acting as a pharmacovigilance contact person and /or LQPPV for the
competent authorities on a 24-hour basis and also for pharmacovigilance inspections.

**REQUIREMENTS**
- Bachelor degree in Pharmacy or Science related
- Minimum 3 years of Pharmacovigilance experience
- Demonstrated ability to be goal orientated, a strategic thinker, innovative/creative and the desire to constantly learn.
- Ability to:

- Effectively innovate, to create efficient and stream



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