Local Safety Officer Dsit

3 settimane fa

Roma, Italia Daiichi-Sankyo Europe A tempo pieno

This position primarily serves as a Local Safety Officer (LSO) for our Italian Affiliate and is accountable to ensure compliance with relevant pharmacovigilance (PV) regulatory requirements globally and locally, and ensuring the local PV system is operating appropriately by executing operational PV tasks.

Act as the local National Contact Person in Italy (as far as required).

This position is accountable for ensuring the proper handling of safety reporting from local to global as well as all other local PV activities (e.g. screening of local literature and monitoring of local PV legislation in the country) in the designated country. The individual will be accountable for managing other DSIT stakeholders (e.g. Marketing, Medical Affairs) as well as local PV vendors, and providing PV Training to relevant local functions and external parties as necessary to ensure PV processes are implemented properly.

This position will report to the DSE PV Partner & Affiliate Manager and is expected to work independently with mínimal guidance with specialized knowledge, and use expertise to analyze and solve problems.

**Roles and Responsibilities**
- Responsible for performing/overseeing all local PV activities in the designated country.
- Ensures safety reports collection process in the designated countries is implemented and oversees the processes are working properly.
- Evaluates and update local SOPs and local appendices to DSE affiliate core SOPs as required.
- Act as primary contact point/nominated person for pharmacovigilance for the Italian Health Authority.
- Contact person for pharmacists, physicians, and consumers for the reporting of adverse drug reactions (ADRs) and PTCs to collect safety information and their follow-up activities.
- Performs/oversees local literature screening, monitoring of local PV legislation, and implementation of Risk Management Plans (RMPs) and additional Risk Minimization Measures at the local level as required.
- Be accountable for managing local stakeholders (e.g. Marketing) as well as local PV vendors, and providing PV Training to relevant local functions and external parties as necessary to ensure PV processes are implemented properly. (e.g. Market Research Programs).
- Contributes to the maintenance of the EU Pharmacovigilance System Master File (PSMF) by providing up-to-date information from the local PV system.
- Contributes to the company’s benefit-risk evaluation for national products and to answering requests from Competent Authorities.
- Acts as a primary contact person for the affiliate audit/inspection in Italy.
- Facilitates the local implementation of global processes as required.

PV process enhancement:

- Contributes to the enhancement of EU affiliate’s PV Quality Management System standards by providing inputs from local PV systems.
- Facilitates the local implementation of global processes (e.g. management of the collection of adverse events, PV regulatory intelligence, management of Safety Data Exchange Agreements).

Vendor/Partner oversight:

- Coordinate periodic communications with partners and ensure the contract is up-to-date and the process is operating well (e.g. PV service providers, Market research vendors)
- Oversees the activities of the PV vendor support

**Skills and Additional Requirements**
- Bachelor’s degree at the minimum required; 5 years of experience with an advanced degree; 8 years of experience with a bachelor’s degree.

(Experience as a Local Safety Officer/local PV responsible person is preferred.)
- Master’s degree in Life Sciences, Pharmacy, or Medical Sciences preferred.
- Possesses strong knowledge of International, European, and PV laws and guidance
- Good or excellent written and verbal communication skills in English
- Highly reliable with accurate operating principles
- Analytic and systematic approach with good problem-solving skills
- Ability to understand complex matters with a continuous focus on improvement
- Substantial communication skills, in particular also on an intercultural level with respect and appreciation of cultural diversity
- Proactive, autonomous, and reliable working style paired with the ability to work in international matrix teams
- Flexible and adaptable

**What we offer**:
**Working at Daiichi Sankyo**:
At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.

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