Head Aggregate Reports

vor 2 Wochen

Basel, Schweiz Healthcare Businesswomen’s Association Vollzeit

Job Description Summary

Designs & develops safety surveillance strategy for products and approval. Responsible for the company’s drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and safety signal detection and risk management assessment for the products’ life cycle. Provides safety support to the clinical development teams.

Job Description

The Head of Aggregate Reports & Risk Management Office, Quality and Strategy is accountable for designing the strategy, establishing the operational quality standards and metrics enabling the tools that support transversally all sub functions in the department. This position guarantees appropriate networking with all other stakeholders internally and externally, ensures that the quality of deliverables is accurately measured and timely reported and is accountable for keeping AR&RM at State of the Art by actively leveraging present tools, investigating future solutions, and executing them.

Your key responsibilities, but not limited to;

  • Lead the team responsible for the Aggregate Reports & Risk Management office, the quality standards and metrics and the strategy team.
  • Enable the tools that support transversally all sub functions in the department. These include applications like COSTA as well as metrics, schedules, trackers, and any future development that facilitates Aggregate Reports & Risk Management deliverables.
  • Explore feasibility of future tools including machine learning and automation through full participation in forward looking projects.
  • Promote strategic thinking for future sustainability of established models in alignment with Global Drug Development and Patient Safety & PV objectives.
  • Understand the present and future capabilities internally and externally for the whole group, performing the forecasts and designing strategies that will allow to maintain a cost effective and sustainable team. Supports team in the search of more automated and rational ways of preparing reports leveraging any opportunity in artificial intelligence (AI)
  • Support teams responsible for preparation of Aggregate Reports, Risk Management Plans and risk minimization strategy/documents/actions and optimizes efficiencies and resources.
  • Collaborate with Patient Safety & PV is responsible for designing, maintaining, and reporting metrics that accurately measure the quality, completeness, and timeliness of the Aggregate Reports & Risk Management reports throughout the organization to ensure compliance with regulations and with internal standards.
  • In collaboration with OPEX and the Aggregate Reports & Risk Management LT is responsible for developing policies and maintaining processes up to date with global legislation for all AR&RM activities
  • Pursue operational excellence and collaboration with all stakeholders in Patient Safety & PV more specifically with Medical Safety, QPPV office, Countries and Regions, PVSO to incorporate their requirements in present and future initiatives.
  • Respond and supports the team in Health Authorities (HAs) inspections and in internal audits.
  • Enable high quality Aggregate Reports & Risk Management’s deliverables, ensures Novartis reputation and safety of patients are always maintained.
  • Deputize for the Head of AR&RM Office, in meetings, boards and as required.
  • Represent Novartis externally; participate and/or join external conferences and networks in regulatory and scientific committees, meetings and associations proactively collaborating to improve the regulatory and scientific framework affecting aggregate reports and RMPs (e.g., ICH, EFPIA…)

Languages:

Fluent in English (both oral and written)

Education

Degree in health or life science, pharmacy, or equivalent relevant degree

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, 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 achieve here at Novartis

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to diversity.inclusion_ch@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Skills Desired

Clinical Research, Clinical Trials, Regulatory Compliance, Safety Science, Team Management #J-18808-Ljbffr

  • (Sr) Safety Scientist/associate Safety Director

    vor 3 Wochen

    Basel, Schweiz BioTalent Vollzeit

    **You will be Responsible For Activities including**: Aggregate case reporting (ICSR), aggregate report (DSUR, PSUR), signal detection/management, safety strategy, input to clinical development strategy (from safety perspective), Risk management (CCDS, IB, RMP, IND/NDA, MAA), support, presentations, publications, vendor relations **You will bring the...

  • Head of Safety Science, Gpv

    Vor 4 Tagen

    Basel, Schweiz Sobi Vollzeit

    Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere. Sobi employs approximately...

  • Head of Controlling 80-100%

    vor 3 Wochen

    Basel, Schweiz HACO AG Vollzeit

    **Head of Controlling 80-100%** *** **Head of Controlling 80-100%** *** **Head of Controlling 80-100%** *** Haco AG - Gümligen - nach Vereinbarung per arrangement en accord Im Bereich Finanzen und Controlling suchen wir eine versierte Persönlichkeit als **Head of Controlling** Unser Controlling-Team leistet als Businesspartner einen wichtigen Beitrag...

  • Head of Controlling 80-100%

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz HACO AG Vollzeit

    **Head of Controlling 80-100%*******Head of Controlling 80-100%*******Head of Controlling 80-100%*****Haco AG - Gümligen- nach Vereinbarung per arrangement en accordIm Bereich Finanzen und Controlling suchen wir eine versierte Persönlichkeit als**Head of Controlling**Unser Controlling-Team leistet als Businesspartner einen wichtigen Beitrag zur...

  • Head of Sales Snacks

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz HACO AG Vollzeit

    **Head of Sales Snacks (m/w/d)*******Head of Sales Snacks (m/w/d)*******Head of Sales Snacks (m/w/d)*****Haco AG - Gümligen- nach Vereinbarung per arrangement en accord- und Müesli-Produkten spezialisiert sind. Neben einem grossen technologischen Portfolio verfügen sie über er- fahrene Teams in Entwicklung, Applikation und Produktion. Mit der Bündelung...

  • Head Patient Centre Outcomes Center of Excellence

    vor 4 Wochen

    Basel, Schweiz Novartis Vollzeit

    394315BR **Head Patient Centre Outcomes Center of Excellence**: Switzerland **About the role** When we put our heads together, we can do brilliant work. And when we do brilliant work, we can achieve remarkable things for patients as we positively transform healthcare. We are looking for a Head Patient Centred Outcomes (PCO) Centre of Excellence. The Head...

  • Site Head

    vor 2 Wochen

    Basel, Schweiz Takeda Pharmaceutical Vollzeit

    **About the role**: As the Site Head for Takeda’s BioScience Plant in Neuchâtel, you will work on-site to inspire and guide the manufacturing team to deliver results for production performance, financial targets, and the highest compliance and safety standards so that the Plant can bring our purpose, values, vision, and imperatives to life. The Neuchâtel...

  • Head of People Services

    Vor 7 Tagen

    Basel, Schweiz Bank For International Settlements Vollzeit

    **Head of People Services (Deputy Head of HR)** The Bank for International Settlements is looking for a Head of People Services (Deputy Head of HR). **Purpose of the job**: Head of People Services (Deputy Head of HR) leads the delivery of HR operational services (HR operations, payroll, talent acquisition and labour leasing) to ensure operational...

  • Head of Safety

    Vor 7 Tagen

    Basel, Schweiz uniQure Vollzeit

    **Head of Safety** **Location**: - Basel (Switzerland) - **Education level**: - MD**Job category**: - CMO Management - **Target start date**: - 3/1/2024**Work Location**: - Hybrid - **Shift**: - 1stuniQure is dedicated to bring innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly...

  • Assistant to The Head of Product

    vor 3 Wochen

    Basel, Schweiz Adecco Human Resources AG Vollzeit

    Critères de l'offre **L'entreprise**: LHH The Adecco Group Switzerland Description du poste We are looking for an Assistant to the Head of Product to join a prestigious watchmaking manufacture It is a permanent contract to start ASAP **You are in charge of**: - Coordination and follow-up of all files related to the Product Department - Organization...

  • Head Planning

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Bayer Vollzeit

    At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...

  • Head of Quality Assurance

    vor 3 Stunden

    Basel, Schweiz Discover International Vollzeit

    Working with a Up and coming Contract manufacturer who have been partnering with the industry for more than 30 Years. Working with a range of companies, and product types, this company has a core focus on Small Molecule Manufacturing. The company is dedicated to developing and distributing high need medicines that improve quality of life worldwide.Head of...

  • Head Patient Centre Outcomes Center of Excellence

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Novartis Vollzeit

    394315BRHead Patient Centre Outcomes Center of Excellence:SwitzerlandAbout the roleWhen we put our heads together, we can do brilliant work. And when we do brilliant work, we can achieve remarkable things for patients as we positively transform healthcare. We are looking for a Head Patient Centred Outcomes (PCO) Centre of Excellence.The Head PCO Centre of...

  • Head of Finance

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Sygnum Vollzeit

    About the role The Finance team in Zurich is responsible for accounting, regulatory reporting, budgeting, management reporting, accounts payable and tax activities for Sygnum Bank AG in Switzerland and Abu Dhabi. The Head of Finance will be responsible for all activities beside many together with the local team. The role will report directly to the Chief...

  • Head of Portfolio Reporting Specialty Lines

    vor 2 Wochen

    Basel, Schweiz Helvetia Versicherungen Vollzeit

    Head of Portfolio Reporting Specialty Lines (w/m/d), Vollzeit oder Teilzeit Basel Führungskraft 50% - 100% Hier geht es für dich hoch hinaus: Helvetia Speciality Lines bieten in der Schweiz und auf dem internationalen Markt massgeschneiderte Versicherungen für Transport, Luftfahrt, Raumfahrt, Kunst und Technik an. Wir können dir also versprechen:...

  • Head of People Services

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Bank For International Settlements Vollzeit

    Head of People Services (Deputy Head of HR)The Bank for International Settlements is looking for a Head of People Services (Deputy Head of HR).Purpose of the job:Head of People Services (Deputy Head of HR) leads the delivery of HR operational services (HR operations, payroll, talent acquisition and labour leasing) to ensure operational excellence, through...

  • Head of Group Treasury

    Vor 4 Tagen

    Basel, Schweiz Straumann Group Vollzeit

    **Global Head of Group Treasury** **Straumann Group Headquarters** **Basel, Switzerland** The Head of Group Treasury is a pivotal role with significant financial, liquidity, and capital structure impacts on the group's landscape. As the leader of the Treasury team, this individual is responsible for managing the Group’s consolidated financial risks,...

  • Head of Safety

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz uniQure Vollzeit

    Head of SafetyLocation: Basel (Switzerland)- Education level: MDJob category: CMO Management- Target start date: 3/1/2024Work Location: Hybrid- Shift: 1stuniQure is dedicated to bring innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This...

  • Head Planning

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Bayer Vollzeit

    At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...

  • Deputy Head of Quality Control Operations

    vor 2 Wochen

    Basel, Schweiz ASM Aerosol-Service AG Vollzeit

    Mit viel Leidenschaft engagieren wir uns täglich für unsere Kunden aus der Welt der Pharma, Kosmetik und Technik. Für deren namhafte Marken sind wir führend in der Entwicklung und Herstellung von hochwertigen Produkten. Zur Verstärkung unseres Teams suchen wir per sofort oder nach Vereinbarung einen motivierten und dynamischen Deputy Head of Quality...