AdresSome opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a multinational biopharmaceutical company with approximately 2,500 dedicated employees serving patients in more than 50 countries through the innovation, development, and commercialization of life-changing therapies. As the global leader in complement biology, Alexion developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). In addition, Alexion has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). Our research efforts focus on novel molecules and targets in the complement cascade, and our development efforts focus on our core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders.
Alexion’s aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team.
Position Summary
This position has primary responsibility in Turkey for ensuring that the collection, follow-up, and onward transmission within Alexion, and submission to health authorities of adverse drug event reports, are managed in compliance with local regulations and company policies/procedures at a local, regional and global level and in accordance with any PV agreements with third-party business partners.
The Local PS Specialist is responsible for appropriate local PV system oversight, including any elements of the PV system that are contracted to a third party. This includes responsibility for ensuring the processes and systems necessary for the employee to fulfill their responsibilities, both internal and out-sourced, for the management of AE reports, comply with global and local requirements; remain current with applicable regulations; and are followed consistently, by ensuring delivery of any training necessary. This position will focus on ensuring RMP activity and post-marketing study commitment compliance with Alexion’s policies and procedures and local pharmacovigilance and international (GVP) requirements.
Position tracks system performance including regulatory compliance, and provides periodic reports to management. By attention to detail, quality and completeness, the position ensures that adverse event information received locally contributes to Alexion’s knowledge of the safety profile of its products. ). This position is part of the global Patient Safety function, and he/she will be reporting to the Middle East Patient Safety director.
Principal Responsibilities
- Ensures and maintains a fully functioning local PV system in Turkey in accordance with the local requirements and internal PV procedures.
- Ensures the timely communication of all PV-related issues to all related stakeholders locally and globally including safety signals, health authority AE requests, intelligence information
- Support the local Regulatory affairs team in regulatory submissions of RMPs, compassionate use periodic reporting, aggregate safety reports and PSP reporting.
- Assume responsibility for the implementation of all RMP and pharmacovigilance activities detailed in the RMP and review the effectiveness and compliance of activities to the applicable regulatory requirements and Alexion policies and procedures.
- Prepare and maintain the Local Risk Management Plans (LRMP).
- Engage with partners and ensure a high standard of partner and third–party oversight in relation to all RMP activities implemented in Turkey, including the collection, review and evaluation of key performance indicators (KPI) for additional risk minimization measures (aRMM) implemented
- Ensure the collection, translation and forwarding of AE information to GVP from various sources including all ICSRs, compassionate use, literature cases and etc.
- Develop and maintain effective business relationships with external parties in addition to tracking performance metrics including regulatory compliance.
- Follow-up adverse events as necessary, providing new and updated information to GVP and logging unsuccessful efforts. Maintains local source documents in accordance with applicable record retention requirements.
- Ensures 24/7 business continuity for the collection & reporting of AEs within Turkey.
- Act as primary contact for GVP in Turkey.
- Executes CAPA plans relevant to the role as necessary,
- Maintains and seeks out a thorough understanding of global and local requirements that relate to the role, identifying and communicating emerging needs to introduce process changes to remain compliant.
- Provides PV expertise to the selection and qualification of any Patient Support Program organized in Turkey.
- Performs root cause analysis of deviations relevant to local PV processes.
- Be part of Global projects and initiatives to improve GVP processes.
- Collaborate with regional and global colleagues to harmonize our way of working across the region.
- Point of contact to provide local expertise on AE reporting processes and standards to local country staff and related contractors/vendors according to Alexion standards and local regulations.
- Maintains oversight of vendors relevant for PV
- Shares best practices with other affiliates in the EMEA region
- Streamlines and develops local processes as required
- Responsible for reporting all pharmacovigilance events, product quality complaints and medical information requests within 24 hours as of awareness according to the local applicable procedures.
Qualifications
- Extensive experience in the pharmaceutical industry experience or equivalent with the majority of experience in a PV functional role (e.g. 3 years)
- Fluency in English language is mandatory..
- Vendor management experience
- Proven expertise and experience in pharmaceutical regulations and R&D processes.
Education
- Life sciences degree, Pharmaceutical degree, Medical degree.
Competencies
- Proven ability to organize workflow activities and manage multiple critical issues.
- Awareness of and familiarity with industry principles of PV, drug development and pharmacology.
- Computer literate with expert knowledge of PV database systems.
- Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external customers.
- Ability to establish and maintain open relationships within the local and global organizations and with local regulatory authorities.
- Demonstrable knowledge of all local PV requirements and of the global aspects of drug safety.
- Able to work independently
- Strong interpersonal and influencing skills
- Understanding of medical terminology and pharmacology.
- PV audit experience.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /Affirmative action employer
