Area Safety Lead, US, Local Pharmacovigilance

Area Safety Lead, US, Local Pharmacovigilance

我们做什么

在 Kenvue，我们意识到日常护理的非凡力量。我们以一个多世纪的传统为基础，植根于科学，是标志性品牌的品牌 - 包括您已经熟悉和喜爱的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科学是我们的热情所在;关心就是我们的才能。

我们是谁

我们的全球团队由 ~ 22,000 名才华横溢的员工组成，他们的职场文化中，每个声音都很重要，每一个贡献都受到赞赏。 我们热衷于洞察， 创新并致力于为我们的客户提供最好的产品。凭借专业知识和同理心，成为 Kenvuer 意味着每天有能力影响数百万人。我们以人为本，热切关怀，以科学赢得信任，以勇气解决——有绝佳的机会等着您！加入我们，塑造我们和您的未来。有关更多信息，请单击 here.

Role reports to：

AD Global Consumer Activity Management

位置：

North America, United States, New Jersey, Summit

工作地点：

混合

你会做什么

The Area Safety Lead (United States) is responsible for ensuring that the local operating company (LOC) safety activities related to all products are managed in compliance with local regulations and company policies/procedures at a local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners.

This role will act as the Local Operating Company (LOC)’s and assigned territories (as applicable) point of contact for pharmacovigilance matters with the local health authority. They will ensure that appropriate product vigilance and risk management systems are set in place to assure appropriate oversight of products within its responsibility.

Key Responsibilities

• Maintain up to date knowledge of local requirements for pharmacovigilance, cosmetic and device vigilances including reporting requirements (for all applicable product classes in the territory) and collaborate with global team to implement process changes required for identification of new requirements

• Support in local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA (Corrective and Preventative Action) plans as applicable.

• Record self-identified non-conformances and collaborate with the global team to investigate non-conformances while developing and implementing effective CAPAs.

• Provide oversight of vendor resources in the countries in scope.

• Act as a delegate for the Area Safety Head, when required.

• Maintain local procedures where applicable and assessing the impact of changes for the global procedure to local procedures.

• Management of PV clauses to be included within local agreements.

• Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.

• Maintain oversight of proper identification of local literature articles for AE reporting as required.

• Perform regulatory monitoring for impact on vigilance activities and responsibilities.

• Ensure reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders) is performed.

• Collaborating with the global and local teams to notify local health authorities of any safety issues including SSI/ESI and Signals.

• Collaborate with the local and global teams to ensure pharmacovigilance compliance of local company sponsored programs and research activities.

• Perform document management and archiving as required.

• Provide technical and strategic input and participate in projects/ workstreams led by the Kenvue Medical Safety teams or LOC.

What We Are Looking For

Required Qualifications

• 4-6 years of pharmaceutical industry experience

• Minimum of bachelor’s degree (health care science professional preferred)

Desired Qualifications

• Experience with vendor resource oversight

• Project management certification/experience preferred

• Ability to organize workflow activities and manage multiple critical issues.

• Excellent verbal and written communication skills.

• Pharmaceutical industry experience including product vigilance responsibility role.

• Awareness of and familiarity with industry principles of product vigilance, drug development, and pharmacology.

• Computer literate with knowledge of relevant IT safety systems.

• Ability to establish and maintain open relationships within the organization and with authorities.

• Demonstrable knowledge of all local requirements and of global aspects of product safety.

#LI-GC1

对您有什么好处

$141,950.00 - $200,400.00

这考虑了许多因素，包括工作地点、候选人的技能、经验、教育水平和其他与工作相关的因素

Kenvue 很自豪能成为一个机会均等的雇主。所有合格的申请人都将根据业绩获得就业考虑，不分种族、肤色、宗教、性别、性取向、性别认同、年龄、国籍或受保护的退伍军人身份，并且不会因残疾而受到歧视。