Senior Pharmacovigilance Associate

Opening: Pharmacovigilance Associate / Senior Pharmacovigilance Associate (APAC)

*please note title and remuneration amount will be considered depending on experience, interview performance and internal equity review

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Role:

Perform case processing for serious adverse events, serious and non-serious adverse drug reactions, and other medically- related project information, such as adverse events of special interest, clinical endpoints and medical information inquiries, literature surveillance, and data retrievals from the safety database. Supports the generation of aggregated safety reports, and Data Monitoring Committees (DMC) reviews.

What you will be doing:

• Review and process serious adverse events, spontaneously reported adverse reactions and/or other medically related information per assigned tasks and study specific procedures• Conducts literature surveillance in the selected database(s) as outlined in the project scope of work and as per established procedures• Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files• Perform safety review of clinical and diagnostic data for case processing• Assist with generation of regulatory reports as necessary to ensure regulatory compliance.• Liaise with other ICON departments, investigational site, reporter, and/or Sponsor as necessary regarding safety issues• Assist with coordination of interdepartmental activities (e.g. listing review, quality control, quality assurance (audits), miscellaneous project activities)• Responsible for effective and efficient development of the Safety Management Plan, including development of specific processes to assure consistency within the project.• Supports creation of the SAE/AE reconciliation plan and supports SAE reconciliation in accordance with this plan and other project specific guidelines.• Assures consistency of plans with client contract and identifies out of scope activities promptly and accurately.• Serve as Functional Lead on case processing or medical information projects as assigned; coordinates teams of Pharmacovigilance associates on project level and serves as the Pharmacovigilance point of contact for project teams.• Effectively maintains the safety database and corresponding entry guidelines, including assurance of quality of data following established quality control process.• Generates data listings from the safety database and assumes responsibility for accuracy of the data.• Supports analysis and quality control during the generation of Aggregated Safety Reports (e.g. Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports).• Supports Safety Scientist in signal detection and risk management activities.• Supports interim data analysis for DMC reviews.• Participates in internal and client project team meetings, including presentation of the safety process at kick-off and investigator meetings.• Reports project status (including monthly metrics) to project/functional management within agreed upon timelines.• Adheres to financial and administrative processes, such as managing project budget and timelines, estimation of resource needs and projected hours.• Proposes solutions for procedural and technical issues.• Supports audits and inspections as required for the assigned projects.• Serves as subject matter experts for case processing and/or medical information tasks in a project team.• Perform other activities as identified and requested by management, including but limited to:• Respond and process medical information inquiries, including inquiries related to adverse events/reactions and product complaints for Clients’ product(s), as per their agreement with ICON.• Assesses reportability of ICSRs based on the project-specific Safety Reporting Assessment sheet.• Submits safety reports to Regulatory Authorities, IRB/ECs, and investigational sites in accordance with relevant legislation and the project-specific contractual agreement, including electronic submission to the EudraVigilance database (EV Web application or Gateway) and other regulatory authorities.• Submits safety reports to licensing partners of PRA clients.• Supports set-up of literature surveillance procedures, conduct of global and local literature searches, resourcing and general oversight for assigned projects.• Effectively coaches and mentors less experienced Pharmacovigilance associates.• Acts as Subject Matter Expert in departmental initiatives.• Contributes to business development efforts in Drug Safety, including presenting safety services at bid defense meetings.For ICON Strategic Solutions, may also include:• Submission of expedited Serious Adverse Event (SAE) reports, Periodic reports, line listings and applicable safety information to clients, Regulatory Authorities, Ethics Committees, investigators, third party vendors, Partners, and ICON personnel, if required & as agreed with client during study set-up, within project specified timelines.• Release of safety reporting intelligence for expedited and periodic reports, line listings, for Regulatory Authorities, Ethics Committees, and investigators within specified timelines.• Maintain a comprehensive understanding of ICON's safety reporting systems, processes, and conventions, as appropriate.• Maintain a comprehensive understanding of ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), guidance documents and manuals associated with safety reporting.• Perform oversight of assigned projects ensuring all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information or for the release of global safety reporting intelligence requirements.• Operate in a lead capacity ensuring ownership and accountability of safety reporting activities or safety reporting intelligence on assigned projects.• Serve as support to the Safety Reporting Group management in all aspects of departmental activities, including but not limited to quality and compliance metric review, finance tracking and oversight, project resource tracking, client engagement, training oversight and CAPA oversight as designated.• Effectively coaches and mentors less experienced associates in all aspects of safety reporting or safety reporting intelligence and other work, as needed.• Participate in client and internal meetings, representing the Safety Reporting department for the assigned projects as designated.• Serve as safety reporting or safety reporting intelligence processor and/or lead for multiple safety reporting or safety reporting intelligence stand-alone projects, providing management support as designated.• Responsible for safety reporting or safety reporting intelligence activities on assigned projects, working in a customer focused approach and an audit and inspection ready mindset.• Demonstrate skills pertaining to client management, safety reporting intelligence, project scope, submission compliance, quality, and budget as designated.• Perform or Supervise periodic reconciliation of adverse event and/or quality  complaint cases within the required deadlines.• Submits safety reports to licensing partners of ICON clients.• Coding Adverse Events in accordance to the applicable standard dictionary• Perform or Supervise periodic reconciliation of adverse event and/or quality  complaint cases within the required deadlines.• Quality Control of activity as applicable

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.  In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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