FR-Deputy Local Safety Officer

This position primarily serves as a Deputy Local Safety Officer (DLSO) for designated country DSFR (France) and is accountable to ensure compliance with relevant pharmacovigilance (PV) regulatory requirements globally and locally. The position ensures the local PV system is operating appropriately by executing operational PV tasks.
This position is accountable for ensuring proper handling of safety reporting from local to global as well as all other local PV activities (e.g. monitoring of local PV legislation in the country) in the designated country. The individual will manage other DSFR stakeholders (e.g. Marketing, Medical Affairs) as well as local PV vendors, and provide PV Training to relevant local functions and external parties as necessary to ensure PV processes are implemented properly.
This position will report to the Local Safety Officer DSFR and is expected to work independently with specialised knowledge and use expertise to analyse and solve problems.

Accountabilities / Measures:
Deputy Local Safety Officer for DSFR:

1. Responsible for performing/overseeing all local PV activities in the designated countries.
2. Ensures safety reports collection process in the designated countries is implemented and oversees the processes are working properly.
3. Evaluates and updates local SOPs and local appendices to DSE affiliate core SOPs as required, in close cooperation with the Local Safety Officer DSFR.
4. Performs/oversees monitoring of local PV legislation and implementation of Risk Management Plans (RMPs) and additional Risk Minimisation Measures as required.
5. Be accountable for managing local stakeholders (e.g. Marketing) as well as local PV vendors.

Providing PV Training to relevant local functions and external parties as necessary to ensure PV processes are implemented properly (e.g. Market Research Programs).

1. Contributes to the maintenance of EU and FR Pharmacovigilance System Master File (EU/FR-PSMF) by providing up-to-date information from local PV system.
2. Acts as a key contributor for the affiliate audit/inspection in France.
3. Facilitates the local implementation of global processes as required.

PV Process Enhancement:

1. Contributes to the enhancement of EU affiliates PV Quality Management System standards by providing inputs from local PV system.
2. 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:

1. Implement/maintain PV agreements/SDEAs with local partners/PV service providers working with internal subject matter experts (SMEs) ensuring all PV requirements are covered in the contract. Maintain contract template as current.
2. 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) and ensure periodic reconciliations are carried out.
3. Oversees the activities of the PV vendor support.

Technical/Professional Knowledge:

1. Previous experience of Pharmacovigilance activity in a France affiliate.
2. Bachelor’s degree in Life Sciences, Pharmacy or Medical Sciences with post-graduate qualification preferred.
3. Possesses strong knowledge of International, European and local PV laws and guidance.
4. A focus on accuracy and integrity.
5. Analytic and systematic approach with good problem-solving skills.
6. Ability to understand complex matters with a continuous focus on improvement.
7. Strong communication skills and an ability to work with respect and appreciation of cultural diversity.
8. Proactive, autonomous and reliable working style paired with the ability to work in international matrix teams.
9. Flexible and adaptable.