Pharmacovigilance Manager

For our Daiichi Sankyo Pharma Canada Limited we are seeking highly qualified candidates to fill the position

Pharmacovigilance Manager 

The Position

This position primarily serves as a Local Safety Officer (LSO) for our Canadian 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 PV Contact Person in Canada. This position is accountable for ensuring the implementation of the DSE PV policy strategy, assuring the local PV system is operating appropriately by overseeing and executing operational PV tasks in Canada.
The individual will be accountable for liaising with other DSCA stakeholders (e.g. Regulatory, Medical Affairs, Marketing) as well as local PV/MI vendors, and providing PV Training to the 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 minimal guidance with specialized knowledge, and use expertise to analyze and solve problems. The secondary role for this position is to act as Interim Medical Information Manager and to support the organization of a customer-centric medical information service in the affiliate in collaboration with all medical
personnel involved in medical information activities. In this role, the employee reports functionally to the Medical Director DSCA.

Roles and Responsibilities

LSO:

• Act as primary contact point/nominated person for pharmacovigilance for the Canadian Health - Responsible for performing/overseeing all local PV activities in Canada.

• Ensures safety report collection process is implemented and oversees the processes are working properly.

• Creates and updates local procedures in line with regulatory requirements and European PV processes.

• Responsible for acting as contact person for pharmacists, physicians, and consumers for the reporting of adverse events (AEs) and Product Technical Complaints (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 a local level as required.

• Be accountable for liaising with local stakeholders (e.g. Medical, 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-todate information from the local PV system.

• Contributes to the company’s benefit-risk evaluation for Daiichi Sankyo products and to answering requests from Competent Authorities.

• Acts as a primary contact person for the affiliate audit/inspection in Canada.

• Closely communicates with the European PV Affiliate Management team and 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).

Interim MI Manager:

• Supporting the Canadian medical affairs team with handling medical information (MI) requests.

• Support with the creation and implementation of the DSE/Canadian MI SOP.

• Liaising with local stakeholders (e.g. Medical Affairs team) as well as local MI vendors to ensure global and local MI processes are implemented properly (i.e., familiarity with MI SOP, systems and platforms).

• Coordinating periodic communications with MI partners and ensure their contract is up-to-date and the process is operating.

• Ensuring oversight of the activities of the MI vendor support.

• PV process enhancement.

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

• 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:

• Implements/maintains 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.

• Coordinates 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 activites of the PV vendor support and of the MI vendor.

Personal Skills and Professional Experience

• University Degree in Life Science  or Master degree in Life Sciences, Pharmacy or Medical Sciences.

• 5 years of experience with an advanced degree .

• 8 years of experience with a bachelor’s degree. 

• Possesses strong knowledge of International, European and PV laws and guidance.

• Good or excellent written and verbal communication skills in English and French.

• 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 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.

• Willingness to travel.

• Flexible and adaptable.