PVMI Associate

Title:

PVMI Associate

Company:

Ipsen Korea

Job Description:

Pharmacovigilance

• Deliver all Pharmacovigilance activities in compliance 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.
• Demonstrate translation capability.
• Maintain an up-to-date list of local journals and/or databases included in regular screening and provide a list of products to the GPS ICSR vendor.
• Oversee the local literature process in alignment with the Job Aid.
• Escalate any signals identified locally or highlighted by local health authority.
• Compile monthly metric reports and perform weekly/monthly reconciliations for adverse events/special situations with internal and with external stakeholders.
• Provide Pharmacovigilance oversight to the delivery of Risk Management Plans, in collaboration with cross-functional teams, and ensure that Additional Risk Minimization Measures are managed according to global and local requirements.
• Provide Pharmacovigilance expertise into all areas of the business as required.
• Collaborate closely with Local Quality Affairs to ensure that product complaints are managed in a compliant, customer-oriented manner, integrating the efficient handling of adverse event reports.
• Handle case safety reports associated with a Product Quality Complaint and a medical inquiry in accordance with local SOPs.
• When requested, prepare, and review accurate, high quality pharmacovigilance reports (including aggregate safety reports and other ad hoc reports), ensuring compliance with local regulatory timelines and requirements, under the supervision of GPS and/or country Leadership.
• Support the business by providing drug safety expertise in reviewing and approving activities related to Patient Data Collection Systems(PDCS), including Patient Support Programs, Early Access Programs, and Market Research Programs
• Ensure that the safety reporting process for local Ipsen sponsored studies and for local PDCS is in place, including any contractual agreements, vendor/investigator training, provide input into AE collection plan and ensure AE reconciliation takes place per the reconciliation plan.
• Monitor local regulatory requirements, document this monitoring, and inform GPS of any changes to local legislation, and update the monthly affiliate report.
• Support and attend affiliate and 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.
• Manage the local affiliate generic PV e-mail inbox.
• Provide local reporting rules and review that they are appropriately set up in the global safety database.
• 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.
• Support Local Medical Information team and Local Quality Affairs to ensure the receipt, management, follow up, and tracking of safety reports from all sources are forwarded to the Ipsen Global Patient Safety ICSR Vendor for entry into the global safety database.
• Support clinical trials by reviewing study protocols to ensure the inclusion of a system for the timely collection and handling of safety information. Manage adverse events associated with the trials and oversee the collection and reporting of all safety information.
• Collaborate with the Legal team to ensure that all contracts with local third parties include the appropriate Pharmacovigilance agreement or safety clauses.
• Maintain oversight of local Pharmacovigilance agreements in the region and collaborate in the review of such agreements as needed. 
• Maintain direct relationship with the third-party partner and oversee the implementation and maintenance of the safety exchange, 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.
• Open deviation for each deficiency or non-compliance with local process and/or local regulatory requirements as needed.
• Perform Root Cause analysis, define Corrective and Preventive Action for non-compliance, and document the corresponding deviation and/or the finding.
• Oversee and track all local deviations impacting Pharmacovigilance.
• Conduct regular reviews of local Quality Documents, such as SOPs and instructions, to ensure compliance with GVP regulatory requirements, global Quality Documents, and local regulatory needs, as applicable.
• Archive PV-related information in accordance with global and local record retention policies and applicable local law.
• Update the monthly affiliate report with the requested information as per template.
• Provide and document Pharmacovigilance training for internal and external staff, ensuring all Ipsen affiliate staff are trained in compliance with local regulatory requirements and global/local SOPs for adverse event/special situation reporting on Ipsen products.
• Coordinate and prepare for regulatory authority Pharmacovigilance inspections and self-inspections and support 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.
• Maintain a working knowledge of internal and external medical information systems.
• Demonstrate translation capability.

Medical Information

• Develop and provide relevant information to external & internal customer in response to unsolicited inquiries regarding Ipsen products and related diseases with accurate, consistent, timely, scientific, and balanced manner.
• Manage and provide responses for escalated inquires as required.
• Develop, update, and manage local SOPs regarding Medical Information job area.
• Maintain and update local Standard Response Document(SRD) and FAQs in accordance with the SOPs.
• Log medical information enquiries not directly received through the PCC vendor into MISTRAL.
• Conduct, document and store reconciliations with Pharmacovigilance and Product Quality Complaints databases and functions weekly.
• Conduct regular Quality Maintenance meetings with the PCC(Professional Contact Center) vendor manager.
• Provide guidance and structure to PCC vendor on training needs, specific enquiry handling and process enquires.
• Act as the MISTRAL super user for the local affiliate.
• Conduct monthly Medical Information Excellence Quality Checks.
• Coordinate and arrange mandatory local training for the PCC vendor.
• Review the Work Order and maintain and update local EHS for the PCC vendor.
• Ensure that Ipsen complies with any applicable local and legal code of practice requirements regarding Medical Information.
• Review promotional and non-promotional materials based on relevant law, guideline, and local regulations.

Qualifications

• Bachelor’s degree in pharmacy, life science, nursing, or a related scientific field. (Pharmacist license is not mandatory but strongly preferred.)
• Minimum of 2 years of experience in pharmacovigilance or relevant roles in pharmaceutical companies is preferred.

Desired Capabilities

• Ability to prioritize tasks.
• Ability to work independently, as a team player and cross-functionally.

Knowledge & Skills

• Knowledge of regulatory requirements and guidelines relating to pharmacovigilance process
• Highly motivated with a focus on process improvement and efficiencies.
• Attention to detail and ability to follow through on commitments.
• Good written and verbal communication skills
• Good interpersonal, decision-making, and communication skills
• Proficient in MS Office applications

Thank you for considering Ipsen as an employer of choice. We wish you all the best with your application.