(Senior) Medical Shared Services Associate

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Purpose:

The purpose of the (Senior) Medical Shared Services Associate role in the Netherlands is to ensure affiliate compliance with internal and external requirements concerning Pharmacovigilance and Regulatory Affairs in the Netherlands, to ensure legal duties are executed and timelines are met. This includes compliance to:

• Drug Safety legal obligations and procedures, documentation and deadlines;
• Labelling and information compliance;
• PSP protocol implementation and compliance;
• Affiliate Labelling Responsible Person (ALRP) activities: perform all tasks related to packaging development and assist the (Senior) Regulatory Affairs Associate.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

DRUG SAFETY

1.1 Responsible for optimizing the value of Lilly products through the promotion of patient safety

• Responsible for basic understanding of Adverse Event (AE) management and workflow elements;
• Responsible for appropriate communications between patient safety local and global and with Product Complaint organization, Medical and Regulatory Affairs;
• To have understanding of the roles and responsibilities of the EU Qualified person;
• Responsible for ensuring compliance with local regulatory compliance and GPS policies, procedures and processes.
• Thorough understanding of laws and regulations;
• Contact person for internal and external parties to ensure/improve compliance of (Serious) AE reporting;
• Act as contact point for agencies regarding pharmacovigilance related topics in case national nominated person is absent. Any issues needs to be escalated to the Executive Director-Pharmacovigilance;
• Responsible for maintaining Pharmacovigilance (PV) training materials;
• Responsible for contacting the Medicines Quality Consultant (MQC), when appropriate.

1.2 AE Receipt and Data Collection

• Ensure identification, retrieval, acknowledgment and distribution of AE information;
• Collect and document all AEs with products reported spontaneously for marketed products and those SAEs associated with clinical trials and post-marketing surveillance studies;
• Responsible for data entry of AE/PC and Follow up info into LAM;
• Responsible for appropriate receipt and managing of AE reports received via Customer Connect, e-mail, letter, phone, in person or through the online AE form;
• Report new or follow-up information as it is received;
• Ensure completion of action items;
• Communicate effectively with AE reporters (confirmation of receipt, follow up of cases entered into LAM);
• Maintain Affiliate AE Tracking Tool.

1.3 Case Management Quality Review

• Review quality of cases entered into LAM against standards;
• Validate data entry against source documentation, where available;
• Review action items and redact follow-up letters to the Health Care Professionals (HCPs) personally or with the Manager - QPV & Medical Shared Service;
• Perform reconciliation and hidden reconciliation with sample checks with patient support programs, and other sources for reporting as appropriate;
• Provide feedback to European Medical Information on the quality of the reports.

1.4 Expedited and Periodic Reporting

• Responsible for submitting Development Safety Update Reports (DSUR) and Line Listings following national guidance and ensure tracking of these submissions;
• Submitting expedited reports from LSS for submission to local regulatory agencies regarding the medical devices in order to meet regulatory requirements and ensure tracking of these submissions;
• Ensure that all reporting timelines are met;
• Responsible for sending the necessary expedited case reports (SUSARs) to ERBs that are required to meet local regulatory requirements and ensure tracking of these submissions.

1.5 Risk Management plans (RMP) AND Risk Minimization Activities (RMA)

• Participate in the preparation of all documents for the submission of RMA materials to CBG according to applicable Dutch regulatory requirements and CBG guidelines;
• Ensure entry and follow-up of RMiP metrics.

1.6 Additional local affiliate responsibilities

• Reporting totals, trends, metrics, deviations and compliance of affiliate (S)AE reporting to appropriate functions such as medical lead and E&C manager;
• Spokesperson for Safety procedures concerning  pharmacovigilance activities during inspections and/or audits of the Medical Department or specific trials/departments;
• Ownership of Required tool Managing AEs in the Netherlands and associated tools;
• Training, supporting and motivating of all new Lilly Netherlands employees with regards to global and local procedures concerning AE reporting;
• Participate to monthly Medinfo hidden AE/PC identification;
• Manage Safety data archive;
• Manage literature screening on AE reporting;
• Updating affiliate metrics for Pharmacovigilance Systems Master File (PSMF), CMTT tool, Zypadhera metrics.

LABELING

• Understand the short and full versions of labels (SPCs/PILs) for use in promotion and by medical information;
• Make sure these (short) versions are made within timelines and transmitted to appropriate stakeholders.

AFFILIATE LABELING RESPONSIBLE PERSON (ALRP)/SUPPORT THE (SENIOR) REGULATORY AFFAIRS ASSOCIATE

• Making translations for product literature (SmPC, Label, PIL and instructions for use);
• Manage general questions from local authorities regarding submitted variations;
• After Approval ensure distribution new approved SmPC’s to internal and external parties as appropriate;
• Responsible for the development, implementation and maintenance of printed packaging components for each Lilly product marketed in the affiliate (MRP and central registrations) in order to deliver consistent, accurate and timely product Information necessary for the safe and effective use of the product;
• Ensure the check and the approval of packaging components. Check translations in English and Dutch;
• Ensure 100% compliance and audit readiness for all packaging related items (training/ SOP/ legislation).

Tr acking of packaging changes

• Track all packaging change notifications in SAIL (Submission and Implementation of Labelling), the application to manage the global labelling business process.

Pre paration of the truth package

• For centrally registered products, as soon as the email from EMA or Lilly Global with the approval date and link to SAIL has been received, download the Dutch texts on the Regulatory LAN drive; compare the texts with the TVT Tool (Text Verification Tool) versus the official published texts in PDF on the EU Community Register website and adapt the texts for the Dutch market regarding adverse event reporting and affiliate contacts;
• For MRP (Mutual Recognition), ensure that Affiliate Product Information is consistent in content with the RMS (Reference Member State) approved documents in English and compliant with local regulations. Ensure the accuracy of labelling translations by conducting approval review and approval process, including working with the Manager - QPV & Medical Shared Service, accountable for ensuring core labelling compliance and that all product information terminology is medically accurate and consistent with current medical practice. This activity is done in collaboration with the (Senior) Regulatory Affairs Associate;
• Open timely a project for PPM development in BLUE (a global application to submit the truth package and check/approve the artwork) and submit an accurate and complete Artwork Request Form (ARQ) and an accurate Final Truth Copy in BLUE;
• In parallel, on the same date, send an email to oneself from the relevant SAIL tracking Item in order to get a project opening tracking date.

3.3. Review/Approval of the Proof Copy

Ensure a thorough review of the Proof Copy received from PPD in BLUE for correctness versus Final Truth Copy, using Text Verification Tool (TVT) and approval or rejection of the Proof Copy with comments in BLUE.

Minimum Qualification Requirements:

• At a minimum a completed Bachelor’s degree and 2 years of relevant experience
• Living in the Netherlands
• Fluent Dutch and English language skills – written and verbal
• Attends national training meetings and symposia as continuing education.
• Ability to interact with diverse groups and individuals
• Knowledge of the local (national) requirements/legislation regarding regulatory submissions and approvals
• Strong administrative skills (e.g. filing and documenting systematics; confidential data handled)
• Able to work in local and international teams
• Excellent communication, interpersonal, and negotiation skills
• Being able to retrieve information in databases
• Medical / pharmaceutical understanding in all therapeutic areas Product basic knowledge

Other Information/Additional Preferences:

• Having telephonic assertively/reachability for direct contacts with HCP, patients and regulators
• Being customer oriented, service minded and pragmatic
• Good understanding of legal/deontological environment in medical affairs and drug safety
• Good resilience to administrative and database encoding tasks
• Be able to work independently and make decisions within guidelines and policies
• Provides sound problem-solving skills to complex issues
• Be able to handle non standard requests from internal and external customers

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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