Patient Safety Manager
5 days ago
**The Position**:
- Lead and develop TH Patient Safety & Pharmacovigilance (LPV) and define the Local PSPV strategy based on the framework provided by global PSPV.
- Develop and define TH 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.
- Acts as local PV contact person/Local QPPV for the national Health Authority as legally required.
**Duties & Responsibilities**:
1. Accountabilities
- Related performance
Local PV Strategy:
- 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.
2. Leads and develops the local PSPV team by living the AAI principles, the BI culture and One Medicine strategy.
- 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 Regional 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.
3. Patient Focus & Intrapreneurship:
- 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.
4. Compliance:
- 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.
**Requirements**:
- Pharmacovigilance experience at least 2 years in MNC Pharmaceutical or CRO company
- Bachelor Degree in Pharmacy or science related field
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