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1. Æ÷Áö¼Ç: Associate PV Manager2. °è¿»ç: Çѱ¹¾á¼¾ (Janssen)3. ±Ù¹«Áö: ¼¿ï½Ã ¿ë»ê±¸4. ±Ù¹« ÇüÅÂ: Regular
[Summary]
¡¤ Ensuring that the Local Operating Company (LOC) safety activities related to medicinal products are managed in compliance with local regulations and company policies/procedures at local, regional, and global levels and in accordance with any Pharmacovigilance (PV) agreements with third party business partners.
¡¤ Having appropriate pharmacovigilance risk management systems and adequate record management in place to assure appropriate oversight for products within its responsibility.
¡¤ Managing Local Medical Safety activities to:
- Ensure proactive Benefit Risk Management throughout product life cycle translating global safety data to insights and actions tailoring to local specificities and needs.
- Support activities related to safety reporting requirements as required by Marketing Authorization Holders (MAH) and/or study sponsor, as applicable.
¡¤ Participating and leading International Pharmacovigilance (IPV) projects and initiatives locally and regionally within APAC cluster. Participating (and may lead) in regional projects and initiatives and providing a supportive role in global projects and initiatives.
[Responsibilities]
¡¤ Ensure that systems and processes are available for the collection and reporting of safety information to meet local and global requirements.
¡¤ Maintain oversight on day-to-day AE inbound and outbound reporting as applicable
¡¤ Oversee data-generating activities to ensure appropriate review and reporting processes are included in project documents for reporting potential AEs (e.g. patient support programs, market research surveys, internet sites),
¡¤ Ensure that day-to-day PV functions are performed satisfactorily and that optimal regulatory compliance is maintained at the LOC level.
¡¤ Maintain overall responsibility for the coordination of safety requirements as delegated by Marketing Authorization Holders (MAH).
¡¤ Act as the local PV contact person for local PV audit and inspection.
¡¤ Ensure awareness of changes in regulations that may have an impact on vigilance activities and responsibilities. Evaluate the impact on local processes and inform the appropriate global and regional groups
¡¤ Ensure adequate local signal detection process if required and ensure reporting of potential single case signals or clusters of similar events seen in case processing
¡¤ Oversee the full product portfolio and link with local management and key stakeholders.
¡¤ Lead and collaborate with cross-functional teams to develop local Risk Management Plans in compliance with local regulations.
¡¤ Collaborate with Medical Affairs and Regulatory Affairs team to ensure that RMP activities are completed in a timely manner
¡¤ Review all risk management plans and PSURs to obtain information on the risk/benefit profile of products
¡¤ Provide Medical Safety input in the pre-authorization phase/submission-planning phase of the product lifecycle to guide appropriate planning and management of RMP-related activities.
[Requirements]
¡¤ More than 6~10 years of experience in PV/Medical safety related field essential; experience working in the pharmaceutical industry is strongly preferred
¡¤ Experience in conducting training
¡¤ Knowledge of PV regulations
¡¤ Experience using a global safety database is desirable
¡¤ Demonstrated attention to detail
¡¤ Excellent written and spoken communication and presentation skills
¡¤ Effective decision maker with the ability to assess the impact of actions taken locally on the global PV system
¡¤ Fluency in written and oral English in order to facilitate communications with GMO, regional Medical, other global functions, and Health Authority
¡¤ High customer orientation
¡¤ Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
¡¤ Sound judgment, strong planning, and organizational skills, and the ability to get things done
¡¤ Demonstrated a strong sense of urgency
¡¤ Strong influencing skills with the ability to explain and defend a position that is in the best interests of patient safety
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