Medical Information Specialist

Job description

The OPEL Medical Information Specialist will develop, maintain and deliver second line for OPEL affiliates and non-affiliate countries. The Medical Information Specialist will also support the MI team with technical aspects and monitoring of content and quality with the medical information outsource service provider and ensure appropriate standards are maintained. Within this position you will have a wide range of responsibilities. You will supply medical information in response to internal and external customer enquiries. Your role will also require you to provide specialist product knowledge to the Business as a whole thereby further contributing to the success of the company. This is an all-encompassing Medical Information role, with a focus on internal engagement with colleagues in the Medical Affairs, Commercial, Quality, Supply, Market Access and Brand teams. Support the Medical Information team with content development, drive and update repositories, intranet pages, tracking etc. Key Responsibilities & Decisions: Establish and develop a strong working relationship with cross functional teams and act as a therapy area expert and provide a quality second line medical information service for affiliates across Europe and Commercial business partners. Promote the safe and effective use of company products by ensuring accurate, balanced and current information is available and provided as appropriate to our customers and other departments Ensure Otsuka standard response documents (SRDs)/ frequently asked questions (FAQs) are accurate, balanced and fair – To avoid Litigation risk, Pharmacovigilance (PV) inspection risk and Code risk. Continually update and review to SRDs/FAQs with all the current literature for designated products/therapeutic areas. Respond to queries from the European Country Affiliates and also direct requests from HCPs / consumers across Europe where necessary. Responding to AE reports/product complaints and queries and ensuring reports are passed to Pharmacovigilance/Quality Operations departments as required. Log and maintain appropriate records. Identifying and organising clinical/clinical trial information on product, competitors and therapeutic area. Expertise in literature searching and journal scanning for products & competitors to identify key papers and information. Evaluating & summarising information, maintaining in-house databases and files. Keep up to date with and comply with relevant company SOPs and working practices, regulations and Codes of Practice. Cross functional working with drug safety, Regulatory and QA departments to ensure accurate response and submission file information. Subsequently responsible for creating Data on File for the European markets as per SOP. Recognition of reported adverse events/product complaints. Support line manager to ensure that any service, whether provided by Otsuka directly or out sourced, will be delivered in compliance with the EFPIA Code plus applicable national codes, the Pharmaceutical Information and Pharmacovigilance Association (PIPA) guidelines on standards in Medical Information, the Data Protection Act, Copyright regulation and relevant Pharmacovigilance rules and requirements. Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organisational needs as necessary. Otsuka is an equal opportunity employer and any applicant who meets the candidate profile is encouraged to apply. Statement Regarding Job Recruiting Fraud Scams At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.