Patient Safety Alliance Manager

326671BR
Sep 02, 2021
India

Job Description

Over 130+ global PV agreements and 1000+ local PV agreements - make a difference every day by end-to-end lifecycle management of Pharmacovigilance Agreements (PVA). Be a part of a dynamic team who oversees, develops and negotiates PV Agreements for licensing IN, licensing OUT and co-marketing of Novartis Group products. Play a direct role in transforming the Novartis Group product portfolio and implementing Vas’ vision to Reimagine Medicine!.

Your responsibilities include, but are not limited to:

• Expertise - Maintain knowledge of current and developing regulations/guidelines for pharmacovigilance and/or device vigilance and provide expertise and advice to all concerned Novartis line-units and external partners for Novartis Enterprise contractual arrangements, for co-development agreements and full marketing agreements, and including support for Clinical Trial Supply Agreements for individual trials and for local vigilance agreements for Novartis Group Companies, as required.
• Negotiate - Manage assigned global vigilance agreements with external business partners by leading negotiations/negotiating team to define conditions of the agreement with external business partners, guided by senior PSAM / PSAH as required.
• Alliance Management – ensure regular contact with key customers to facilitate agreement compliance and good relations, and acting as key contact person for external and internal stakeholders to identify needs and address resolution of issues.
• Regulatory Compliance – with PSAH communicate requirements to CMO&PS functions and ex-ternal line-units to ensure compliance with global vigilance agreements; with PSAH and Compliance Team, ensure external business partners and CMO&PS management are alerted to compliance and reconciliation issues and have oversight of corrective actions and their ef-fectiveness to improve and maintain a high level of compliance.
• Local vigilance agreements – Supervision and control of local vigilance agreements, as required, to adhere to GDD CMO&PS standards. Vigilance Agreements for Clinical Trial Supply Agreements - Support and advise CMO&PS and concerned Novartis line-units on how to meet vigilance requirements for Clinical Trial Supply Agreements, including compliance monitoring as required.
• Maintenance - ensure timely renewals and appropriate updates to vigilance agreement are implemented as required to maintain regulatory compliance and GDD CMO&PS standards. En-sure accuracy and up-to-date information of agreements in the vigilance agreement reposito-ry/ies.
• Database configuration - communicate data configuration requirements to PVSDM to ensure accurate and complete automatic distribution of case reports to licensing parties and ensure that expediting requirements are regularly reviewed and verified in collaboration with Alliance Compliance Member.
• Training and communication – Assist in the development, maintenance and training Novartis CMO&PS and other concerned departments on worldwide Novartis pharmacovigilance stand-ards & procedures for pharmacovigilance agreements, using internal guidelines, tools and templates. Represent PSA (Patient Safety Alliance) in internal and external meetings as needed, guided by Senior PSAM / PSAH as required.

Minimum Requirements

• Degree in Biomedical Science or related scientific discipline. Higher degree desirable. Fluency in spoken and written English, knowledge of other languages desirable but not required.
• Minimum 3 years’ experience in clinical safety/pharmacovigilance or in a regulatory/compliance related area including a thorough knowledge of the functional requirements of clinical safety reporting and a clinical safety database.
• Good current knowledge of industry regulations and guidelines in the field of Pharmacovigilance and/or device vigilance.
• Experience in Clinical Trial Safety (including interactions with Clinical Teams, review of safety section of protocols, Safety Specifications Worksheets and Validation and Planning Documents, production of SAE workflows, completing safety database configuration requests, clinical trial case processing/evaluation) preferable.
• Strong interpersonal communication skills; Strong negotiation/problem solving skills. Experience and ability to work in matrix cross-functional environments. Cultural awareness and sensitivity; open and honest.
• Organizational skills, planning, prioritizing and flexibility to adjust to changing deadlines and priorities; ability to work independently and under pressure.
• Leadership skills for leading meetings, negotiation teams and implementation training.

WHY NOVARTIS
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
CMO & PATIENT SAFETY GDD
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
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326671BR

Patient Safety Alliance Manager

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