Job Summary
Data - Join our dynamic team as a Pharmacovigilance Specialist where you will play a crucial role in ensuring the safety and efficacy of pharmaceutical products. With a focus on Pharma Research and Development you will contribute to the monitoring and reporting of drug safety data. This hybrid role offers a rotational shift schedule providing flexibility and the opportunity to make a significant impact on public health.
Responsibilities
- Monitor and evaluate adverse event reports to ensure compliance with regulatory requirements and company standards.
- Collaborate with cross-functional teams to analyze safety data and identify potential safety signals.
- Prepare and submit aggregate reports such as PSURs to regulatory authorities in a timely manner.
- Conduct thorough research and development activities to support the safety profile of pharmaceutical products.
- Utilize your expertise in Pharmacovigilance and Safety Operations to enhance drug safety monitoring processes.
- Provide technical guidance and support to team members in the analysis and interpretation of safety data.
- Develop and implement strategies to improve the efficiency and effectiveness of safety reporting systems.
- Ensure accurate documentation and maintenance of safety data in compliance with regulatory guidelines.
- Participate in the development and review of standard operating procedures related to pharmacovigilance activities.
- Collaborate with stakeholders to address safety-related inquiries and provide expert advice.
- Contribute to the continuous improvement of pharmacovigilance processes and systems.
- Support the training and development of team members in pharmacovigilance practices.
- Engage in regular communication with regulatory authorities to ensure alignment on safety reporting requirements.
Qualifications
- Possess a strong background in Pharma Research and Development with a minimum of 4 years of experience.
- Demonstrate expertise in Aggregate (PSUR) reporting and Pharmacovigilance and Safety Operations.
- Exhibit proficiency in analyzing and interpreting complex safety data.
- Display excellent communication and collaboration skills to work effectively in a hybrid work model.
- Show adaptability to rotational shifts and a commitment to maintaining high standards of safety reporting.
- Hold a relevant certification in Pharmacovigilance or a related field.
Certifications Required
Certified Pharmacovigilance Professional (CPP) or equivalent certification.
コグニザントについて
コグニザント（NASDAQ: CTSH）は、AI Builderおよびテクノロジーサービスプロバイダーとして、お客様にフルスタックのAIソリューションを構築することで、AI投資と企業価値を結ぶ架け橋となっています。業界、ビジネスプロセス、エンジニアリングに関する当社の深い専門知識を活かし、組織固有のビジネス環境をテクノロジー・システムに組み込みます。これにより、人間の可能性を最大限に引き出し、確かな成果を実現するとともに、急速に変化する世界においてグローバル企業が常に一歩先を行くための支援を行っています。 詳細については、cognizant.ai をご覧ください。
雇用に関する追加情報
本募集に記載されている報酬情報は、掲載日時点で正確なものです。Cognizantは、適用される法令に従い、いつでも本情報を変更する権利を留保します。
応募者は、対面またはビデオ会議による面接への参加を求められる場合があります。また、各面接の際に、現在有効な州政府または政府発行の身分証明書の提示を求められる場合があります。
Cognizantは機会均等雇用主です。応募および選考において、人種、肌の色、性別、宗教、信条、性的指向、性自認、国籍、障がい、遺伝情報、妊娠、退役軍人の地位、その他連邦法・州法・地方自治体の法律により保護されるいかなる特性に基づく差別も行いません。
