Area Safety Lead, US, Local Pharmacovigilance

Area Safety Lead, US, Local Pharmacovigilance

私たちがしていること

Kenvueで、日常のケアの並外れた力を実感します。100年以上にわたる伝統を基盤に、科学に根ざした当ホテルは、ニュートロジーナ®、アヴェーノ®、タイレノール®、リステリン®、ジョンソンズ®、バンドエイド®など、すでにお馴染みのアイコニックなブランドを展開しています。科学は私たちの情熱です。ケアは私たちの才能です.

Who We Are

私たちのグローバルチームは~22,000人の優秀な人々で、すべての声が重要で、すべての貢献が評価される職場文化を持っています。 私たちは洞察に情熱を注いでいます。 革新とお客様に最高の製品を提供することに取り組んでいます。専門知識と共感力を持つKenvuerであることは、毎日何百万人もの人々に影響を与える力を持つことを意味します。私たちは人を第一に考え、熱心に気を配り、科学で信頼を勝ち取り、勇気を持って解決します。そして、素晴らしい機会があなたを待っています!私たちと一緒に、私たちの、そしてあなたの未来を形作りましょう。詳細についてはをクリックしてくださいhere.

Role reports to:

AD Global Consumer Activity Management

Location:

North America, United States, New Jersey, Summit

勤務地:

ハイブリッド

あなたがすること

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

それは何ですか

$141,950.00 - $200,400.00

これは、勤務地、候補者のスキル、経験、教育レベルなど、多くの要素を考慮に入れています。その他の仕事関連の要因.

Kenvueは機会均等雇用者であることを誇りに思っています。人種、肌の色、宗教、性別、性的指向、性同一性、年齢、出身国、または保護された退役軍人の地位に関係なく、すべての資格のある応募者は、能力に基づいて雇用の検討を受け、障害に基づいて差別されることはありません。