At Ipsen our strategy is to build a global biopharma company focused on innovation and specialty care which delivers differentiated therapeutics to meet unmet patient needs. Ipsen is already a growth story. But with focus on our key strengths – our portfolio, our pipeline, our partnerships and our people – we can look forward to further innovative and sustainable growth in the years to come.
We now seek a Local PVMI Specialist (Temporary Fix Term) for our South Korean affiliate.
Purpose of the position
- Execute Local pharmacovigilance / Medical information activities in-country
- Ensure local PV & MI process are updated and inspection ready
Main Task and Responbilities
PV Roles And Responsibilities
- Ensure all PV activities are delivered in line with local guidelines, legislation as well as local and global Ipsen Policies and SOPs
- Ensure the accurate, timely reporting and follow-up activities of all adverse events and special situations reports and have necessary translation and quality steps in place
- Have translation capability
- Ensure review of literature for collection of AEs and Safety Signals
- Escalate any signals identified at local level or highlighted by local health authorities
- Compile monthly metric reports and perform weekly/monthly reconciliations for adverse events (internal and with external partners)
- Provide Pharmacovigilance oversight to the delivery of Risk Management Plans in conjunction with the cross-functional team, as applicable and ensure ARMMs are managed per global and local requirements
- Provide Pharmacovigilance expertise into all areas of the business as required.
- Ensure local Ipsen has a comprehensive local PV system
- Work with the quality head for product complaints so that both product complaints and adverse event reports are handled in a compliant and customer service-oriented manner.
- When requested, prepare and review accurate, high quality pharmacovigilance reports (aggregate safety reports and other ad hoc reports) and documentation, within agreed regulatory timelines, to assist in meeting local regulatory requirements, as required under the supervision of GPS, and/or country Leadership.
- Support the business through the provision of drug safety expertise in the review and approval of activities such as Patient Support Programs and Patient Data Collection Systems
- Act as the local contact for all Patient Data Collect Systems (PDCS):
- Provide training and support with regards to PV requirements on PDCS’s to Ipsen colleagues
- Assess program for eligibility and liaise with the GPS solicited team
- Ensure all documentation is completed, PV training is provided, and that the Global Inventory is updated
- Perform regular review of local regulatory requirements and best practices and inform the QPPV Office and/or GRA of any changes to local regulations that affect the reporting of safety data and associated reports.
- Support and attend affiliate/GPS meetings to ensure awareness of any changes in global and/or regional requirements of the PV system
- Escalate safety, compliance and operational issues to GPS in addition to the local Leadership.
- Provide local reporting rules and review that they are appropriately set up in the global safety database.
Cross-functional and oversight role
- Liaise with all functions including Commercial partners, Service Providers, third parties, and other Ipsen functions like medical affairs, regulatory affairs, medical information etc. to have an overview of processes impacting PV affiliate workflows
- Demonstrate scientific and business expertise relevant to therapeutic areas, including products, disease state management, emerging therapies, and the competitive landscape
- Maintain a working knowledge of internal and external medical information systems
- Provide support to Medical Information and Product Complaint teams to ensure the receipt, management, follow up, and tracking of safety reports from all sources are forwarded to the Ipsen Global Patient Safety (GPS) Case Processing Center for entry into the global safety database.
- Act as the PV contact for all Ipsen sponsored local clinical trials
- Support clinical trials by reviewing study protocols to ensure inclusion of a system for timely collection and handling of safety information. Handle adverse events associated with the trials and manage collection and reporting of all safety information
- Provide GPS and local management with outcome reports on all safety related activities
- Work with the legal team to ensure that all contracts with local third parties include the appropriate PV agreement or language
- Maintain oversight of any local/global PV agreements in the region and collaborate in the review of such agreements as required. Maintain direct relationship with the third-party partner and be responsible for oversight of the implementation and maintenance of the safety exchange with the partner, including monitoring compliance.
- Collaborate with Global Regulatory Affairs to confirm specific local requirements for aggregate reports (i.e. Regional specific appendices) and to ensure compliance
- Coordinate with Global and local medical affairs on any ongoing studies
- Provide information as required by or requested to support the maintenance of the EU PSMF
Training, Audit, Inspection and CAPA management role
- Ensure that regular, documented audits of the local PV system take place
- Coordinate and input into deviations and CAPAs (Corrective Action and Preventive Action) where necessary
- Document and track deviations from PV processes and ensuring that appropriate CAPA are developed and implemented to address issues with compliance
- Perform regular review of local Quality Documents such as SOPs and Instructions to ensure that they are compliant with GVP regulatory requirements and global Quality Documents as well as local regulatory needs as applicable
- Ensure that the PV team archiving is done in a timely fashion and in line with Ipsen SOPs and regulatory requirements
- Partnering with Training to develop and update training programs and present to new hires
- Ensure that pharmacovigilance training courses are provided and documented for internal and external staff such that all Ipsen affiliate staff are trained in compliance with local regulatory requirements and global/local SOPs for adverse event reporting on Ipsen products.
- Coordinate and prepare regulatory authority PV inspections and internal affiliate country office audits and supporting the development of responses to findings.
- Participate in inspections and audits and conducting audits as needed.
- Support with the GPS and the country Leadership to ensure a PV Business Continuity Plan is in place and tested.
Medical Information Service
- Providing accurate and high quality of medical information to internal and external customers timely, by ensuring safe and effective usage of products
- Handling medical information queries from internal and external customers
- Doing a role as user of MISTRAL system
- Managing SRD (Standard Response Document)
- Reviewing promotional and non-promotional material
- Work with GMI (Global Medical Information)
Experience / Qualifications
- Prefer Pharmacist License holder
- Prefer to have experience of pharmacovigilance/ MI work within the pharma industry or relevant field
- Knowledge of regulatory standards related to pharmaceutical manufacturers’ communications.
- Knowledge of clinical trial and drug approval process, clinical application of drug products
- Knowledge of drug information communication and management
- Excellent written and verbal communication skills with experience in medical writing
- Local language (Korean): Read, Write, Speak
- English: Read, Write, Speak
- Literature database search/review skills
- Excellent interpersonal and communication skills
- Strong organizational and management skills
- Ability to prioritize tasks
- Ability to work independently and as a team player
- Be result oriented
- Knowledge of MS WORD, Excel, PowerPoint, and grant management system
Thank you for considering Ipsen as an employer of choice. We wish you all the best with your application.