Job DescriptionResponsibilities:The Specialist is responsible for all PV and RA submission requirements and PV activities for their assigned product portfolio as applicable (medical device and pharmaceutical products.The Specialist collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules such that there is no gap in adverse event reporting and drug safety oversight.The Specialist is also responsible for other activities (as delegated/assigned by their manager) which may include but are not limited to: review of local PV and RA agreements, local due diligence activities, participation in audits and inspections and related readiness activities, review of local initiatives for compliance with PV requirements, authoring/reviewing SOPs, training, communication of safety issues, developing product registration plans and strategies. The incumbent must have a health, life science, or medical science degree or equivalent by education / experience and be fluent in English (written and spoken) while proficient in local language. He/she should have a minimum of 1 year of industry experience in in pharmacovigilance and/or regulatory affairs. He/she must have a general knowledge of PV/RA regulations within his/her assigned country and be an expert in PV & RA processes/activities. The Sr. Specialist is expected to have good communication and time management skills.Responsible for day-to-day adverse events/ incident case management including case intake and follow-up activities in accordance with Global Pharmacovigilance procedures and country regulations. Responsible for the intake of cases received from the designated point of contact, Vendors, and Business Partners for Individual case safety reports (ICSRs) including tracking and translation to English and forwarding of information to the Data Management Center. He/she also performing ICSR acknowledgments and reconciliation activities. Responsible for execution of local PV and RA processes and activities in alignment with PV and RA systems and their associated Quality Management System, following department SOPs, company Policies and Procedures and country legislation. Assist in development of product registration plans & strategies and working cross-functionally to review & communicate the registration strategy with management oversight. Assist in timely preparation, submission of new Marketing Authorization Applications to local Health Authorities, maintenance of authorized products through timely submission of post-market regulatory dossiers, including but not limited to variations, renewal applications and supplemental marketing authorizations in accordance with local regulations and global standards. Performs reconciliation activities for PV cases received from local operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners (as applicable) and processes the reports in accordance to local procedures/ PV legislations. Provides support for Patient Support Programs (PSP) and/or Market Research vendor(s) related activities, as applicable. Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements. Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues. Supports local PV audits and inspections including readiness activities and supports other audits/inspections including the development of CAPAs in response to findings/observations. Participates in and supports audits of contractual partners/vendors as necessary. May be trained and assigned responsibility to conduct qualification and ongoing audits of vendors and perform due diligence activities for local country licensing agreements. Assists in developing local procedures (in compliance with regional and global standards) for the department, to ensure quality PV and RA data and evaluates processes for potential improvement in efficiency and effectiveness. Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders. Supports training of the local company staff, distributors, vendors, business partners including training documentation. May be assigned responsible for ensuring PV language is included in local agreements and ensuring maintenance of BDLM with respect to local and regional contracts. Contributes in the maintenance of regulatory licenses including, but not limited to, import, distribution, Medical Device. May be assigned to support drug shortage management and regulatory requirements for reporting including collaborating with Head Quality Assurance to avoid supply constraints and ensure constant audit-readiness. As delegated, ensuring the awareness on obligations to comply with regulatory requirements and any other applicable statutory requirements and any decision thereof made by top management throughout the establishment and supply-chain. Maintenance of Poison License A requirements.Regulatory Affairs:Technical changes management Label updates (non safety, safety, HA Directives, etc) & artwork maintenance HA request, post-market sampling Inquiries by CMC, RAI OOS notification to HA Renewal (internal preparation and external submission) Maintenance of product dossier/ folder Maintenance of product records in Reliant Archiving activities Tender document requestsPharmacovigilance:AE/ incident intake case process and follow up Archive cases submission to HA NSS related issue- communication to HA PBRER submission RMP submission DHPC/ FSN (safety communication) Safety information requested by HA PVA- alternate projects(non-exhaustive list, delegated as necessary)Primary skills include but are not limited to:Collaboration and Partnering: Demonstrates ability to work in partnership with others (internally and externally) to accomplish quality goals. Communication Skills: Demonstrates good communications skills to convey and receive information in English and local language. Problem Solving: Demonstrates good skills in problem solving Project Management: Demonstrates good skills in the ability to organize work efforts, prioritize tasks and utilize appropriate resources to support PV and RA activities in accordance with timelines and appropriate regulations. Decision Making: Demonstrates strong skills to utilize knowledge, networks and data to make rapid and appropriate decisions with management oversight and to determine when escalation of issues is necessary. Regulatory and Compliance Management: Demonstrates knowledge of PV and RA regulations and regulatory trends.Must have requirements:- a minimum of 3 year of industry experience in in pharmacovigilance and/or regulatory affairs.Pharmacist with licence A holderSecondary Job DescriptionWho We Are: Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. Annualized Salary RangeAnnualized Salary Range (Global)Employee Status: RegularRelocation:No relocationVISA Sponsorship:Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisitesFlexible Work Arrangements:Shift:Valid Driving License:Hazardous Material(s):Number of Openings: 1
