Apprentie Global Patient Safety

POSITION

Job Title:

Apprentice GPS Regional Team, Europe

Division / Function:

GPS Regional Team

Manager’s Job Title:

GPS Regional Manager Europe

WHAT - Summary & Purpose of the Position

To …

• Actively support the GPS Regional Team in contributing to a strong oversight of all Pharmacovigilance activities performed in Europe by Ipsen Affiliates and Ipsen partners
• Actively support the Ipsen Affiliate Pharmacovigilance Offices to maintain their Ipsen Pharmacovigilance System in accordance with Ipsen global policies and regulations in place.
• Actively support the GPS Regional Team in ensuring compliance at Affiliate and partner level with the defined processes/contracts
• Actively support the GPS Regional Team in liaising with Commercial Partner acting as local PV representative and /or as MAH to ensure compliance and performance of the PV services delivered by these commercial partners

WHAT - Main Responsibilities & Technical Competencies

• Oversight of all Pharmacovigilance activities performed in Europe (Affiliate and partner level)

• Participate to the catch-up meeting host by the Regional team with each Affiliate in Europe
• Contribute to the redaction of meeting minutes and pending actions discussed
• Coordinate pending actions from catch up meetings with other stakeholders within the GPS organization, other global departments, and the affiliate.
• Coordinate any query asked by GPS to the Affiliates in Europe for GPS Regional team oversight
• Assist in the slide preparation for Monthly meetings with Affiliates and GPS organization.
• Support of the PV system maintenance at Affiliate level
• Coordinate the implementation of relevant changes of global quality documents impacting the affiliate processes
• Support each affiliate who raise any questions related to Ipsen requirements by coordinating the response with the subject matter expert
• Compliance of the PV activities performed by Affiliates and Partners
• Conduct Quality checks of the monthly reports completed by each affiliate and partners in Europe to ensure data provided is accurate, comprehensive, and exhaustive.
• Escalate any issue identified during the review to the GPS regional lead and Manager
• Assist the GPS Regional Team in the certification of PDCS and DM

HOW - Behavioural Competencies Required

Collaborates Building partnerships and working collaboratively with others to meet shared objectives.

• Collaborates and communicates without boundaries, continuously removes organizational barriers;
• Focuses on continuous improvement; integrates and leverages key learnings, showcases resourcefulness, learning/experimenting at scale, demonstrates strong entrepreneurial behaviors and mindset

Ensures Accountability : Holding self and others accountable to meet commitments.

• Ensures single accountable referents per task/project/outcome (independent of organizational context or multi-team projects);
• Builds and anchors an environment where people have the skills and habits to ask for clarification when accountabilities are unclear;
• Consults/seeks relevant stakeholder views/expertise and coaches/ensures decisions are made by consent vs. consensus;
• Takes personal accountability for decisions, actions, successes and failures, and fosters the same for others;
• Follows through on commitment and makes sure others do the same

Manage Complexity : Making sense of complex, high quantity, and sometimes contradictory information to effectively solve problems.

• Identifies contradictory information/demands/inputs to effectively solve problems;
• Develops and evaluates alternative scenario and solutions;
• Able to identify what truly matters and ruthlessly focus/ prioritize on making decisions with real impact.

Excellence in execution Planning and prioritizing work to meet commitments aligned with organizational goals. Consistently achieving results, even under tough circumstances.

• Approaches priority setting and setting the stage through the lens of execution;
• Establishes clarity about the goals, accountabilities, timelines, and next steps; can identify/spot opportunities for real impact on patient and society;
• Able to be focused and performance-driven with clear KPIs
• Plans and aligns effectively (steps, resources, timelines etc.);
• Displays a commitment to best practice sharing and setting
• Promotes single point of accountabilities

Influences: Using compelling arguments to gain support and commitment of others. Anticipating and balancing the needs of multiple stakeholders;

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• Have a basic knowledge of pharmaceutical industry and Good Pharmacovigilance Practices
• Ability to work in a matrix environment
• Team player with good networking
• Ability to prioritise own workload, work under pressure and achieve strict timeline targets
• Good verbal and written communication skills

Education / Certifications (essential):

• Pharmaceutical science 5th or 6th year

Language(s) (essential):

• Fluent in written and spoken English