Pharmacovigilance Associate

Partial Home-base, Pharmacovigilance Associate, Seoul, South Korea

You will have an opportunity to work in a solid partnership and an environment driven by innovation and continuous improvement. This program is for you if you are looking for an environment where people feel they belong and are empowered to reach their full potential, perform at their best and make a valued contribution to saving lives.

What you will be doing:

Basic purpose of the job
Ensures the establishment and maintenance of a local Patient Safety and Pharmacovigilance (PS & PV) system to support patient's and clinical trial subject’s safety and public health in the assigned territory; South Korea. Fulfills compliance with external requirements in line with the local PV legislation and applicable internal procedures and processes allowing the company to obtain and maintain marketing authorization of its products.

Accountabilities
1. Responsible for management of PV relevant information received locally (e.g. ICSR collection, local processing, follow-up, reconciliation, documentation and archiving) including PV reporting to local Health Authorities/Ethics Committees in line with applicable regulations
2. Implements activities to enhance PV compliance culture and PV awareness at local level of the organization in line with global recommendations
3. Maintains appropriate PV knowledge to ensure that Company fully complies with PV-relevant regulations in the respective territory. Proactively cooperates with PV Intelligence, GPV Operations and other Line Functions such as Regulatory Affairs on any upcoming new regulations to assess the local impact and their implementation.
4. Contributes to benefit-risk assessment of company product portfolio:
• keeping the respective PVWG Chairperson up-to-date on any new safety information received from local sources for company products or for products of the same class
• supporting the implementation of RMP commitments in cooperation with the global PVWG and relevant local functions
5. Acts as the key expert for any PV-relevant topics and ensures proactive communication as appropriate:
• Gives PV input to local / Regional innovative drug development and marketing activities such as Compassionate Use Programs, Non Trial activities, Non-Interventional Studies in liaison with GPV functions
• Regularly updates the local Leadership team about the performance of the local PV system and proactively escalates any issue
• Ensures appropriate PV training of all company staff and those working on behalf of BI in the respective territory
• Manages local Pharmacovigilance Agreements (PVAs) in cooperation with Global Partner Management
6. Contributes to the PV Quality system in
• ensuring that the PV Local Working Instruction and the local PV system repository correctly describe the local PV system and reflect global PV-relevant processes as well as specific local requirements
• ensuring local PV inspection readiness and participation in PV audits and local PV inspections
• cooperating with GPV compliance in identification of PV and PV-relevant non-compliances (NCs) occurring during routine business and timely CAPA development and implementation as assigned for NCs, observations from PV audits and inspections.
• ensuring that an up-to-date PV business contingency plan is in place.
• Screens local scientific literature for identification of PV relevant information.
• Prepares local periodic reports and local RMPs with country-specific format and content if needed in liaison with GPV functions.

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You are:

• Excellent knowledge of relevant Pharmacovigilance regulations and GCP, technical knowledge of drug safety databases regarding submissions and safety information exchanges.
• Minimum Education/Degree Requirements
• Pharmacy degree / Life-Science degree is acceptable
• Required Capabilities (Skills, Experience, Competencies)
• Experience in working in a diverse fast pace environment
• Demonstrated ability to multi-task
• Have structural, organizational, communication and prioritization skill
• proactive and assertive attitude
• balanced decision making
• Fluent in English communication
• +2 yrs PV experience
• 1 yr fixed-term contract position

Why ICON?

At ICON, we embrace new perspectives and empower our people to write their own paths forward. We are a culturally diverse company with over 40,000 talented and ambitious people with varied skills, perspectives & backgrounds working together across 40 countries.

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, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.