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  • Posted: Oct 30, 2023
    Deadline: Not specified
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  • Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a bill...
    Read more about this company

     

    Local Medical Safety Specialist

    Main responsibilities:
    Local Medical Safety Responsibility & Benefit Risk Management:

    • Establish Product knowledge with a focus on safety profiles, Therapeutic Areas, and Disease Pathway knowledge supporting the needs of the local Medical and Marketing organization in collaboration with the International Medical Safety leader or MSO and the Country Safety team lead (CSTL)/Local Safety Officer (LSO) as applicable.

    Aggregate reports:

    • Work with LSO/CSTL to provide medical input and insights for aggregate reports while undertaking a local review and ensure the submission of Periodic Safety Update Reports (PSURs/DSURs), as applicable,
    • Plan and ensure timely submission of Aggregate Reports according to local regulations.

    Pharmacovigilance-Safety training support:

    • Support LSO/CSTL in the preparation, conduct and timely documentation of Pharmacovigilance training for Local Operating Company employees, and Adverse Event and Product Quality Complaints (AE/PQC) training to distributors/3rd-Party vendors and with the translation of AE/PQC material, where needed.
    • PV contract management:
    • Support LSO/CSTL with the local Pharmacovigilance Agreements (PVAs) preparation and implementation, including Local Safety Unit (LSU) training and adherence to PVAs,
    • Coordinate the provision of support for third-party safety agreements locally e.g. local Vendor Agreements as necessary, and seek support from central functions like PV Service and Technical Contracts Group and International PV(IPV) Affairs as needed.

    Safety regulations:

    • Support CSTL/LSO in detecting and reporting PV regulatory requirements for MAH,
    • Support in the review of new/revised safety regulations (for drugs non-medicinal products & Medical Devices in the scope of responsibilities), evaluation of the impact on the local processes, and notification of appropriate global and regional groups via the central PV policy tracker (new requirements and or updates).
    • Local Safety compliance (PV and non-medicinal product safety) :
    • Provide insights on compliance metrics to CSTL/LSO
    • Support LSO/CSTL with Corrective Action & Preventive Action (CAPA) implementation, procedural document review from Subject Matter Experts and Area leads - depending on the topic
    • Support in Impact assessments and action as required on a local level
    • Provide content to the Pharmacovigilance System Master File (PSMF) contributions and data, as needed, accurately and in a timely manner.
    • Responsible for the local PSMF implementation and maintenance for countries of responsibility, where applicable.
    • Pharmacovigilance and Vigilance Service Provision:
    • Collaborate with CSTL/LSO to ensure that day-to-day Pharmacovigilance and safety activities for non-medicinal products (i.e., medical devices, commodities, nutritional) are performed satisfactorily and that full regulatory compliance is maintained at the Local Operating Company level including adequate record management.

    Job Requirements:

    Qualification & Experience:

    • Minimum of 1-2 years pharmacovigilance experience in the pharmaceutical industry
    • Degree/Advanced Degree in medicine or life sciences/ Pharmacy (B, Pharm or D, Pharm) preferred
    • Knowledge and familiarity with industry principles of product vigilance, drug development and pharmacology
    • Proficiency in Medical terminology (local languages)

    Knowledge & Skills:

    • Good verbal and written communication skills, fluency in local language(s) and English language required
    • Good in data analysis and reporting
    • Proficiency in global and local SOPs
    • Ability to negotiate and communicate with internal and external customers.
    • Ability to establish and maintain open relationships within the organization and with authorities.
    • Ability to manage multiple critical issues and work under pressure

    go to method of application »

    Brand Manager Haematology

    Duties & Responsibilities:

    Business Management:

    • Develop a long-term vision and mission for IMM / Gastroenterology business in UAE and create a roadmap with the relevant business stakeholders.
    • Review the plan with key stakeholders, including senior management, and ensure it is implemented both internally and externally.

    Analysis:

    • Market Research: seek advantages/disadvantages of MR instruments and types of research (quantitative and qualitative) and apply this knowledge to seek strategic insights.
    • Forecasting (including sales): manage customer/marketplace parameters and forecasting models and business drivers (i.e., business and strategic plan forecasts) to deliver the financial expectations of the brand; constantly strives to identify and answer key strategic questions that can impact the forecast.
    • Sales Analytics: identify best practices and gaps in brand performance and apply this knowledge to influence sales force structure and compensation (where appropriate) to be competitive in the market and achieve brand growth goals.
    • Related Research Activities (RRA).
    • Ensuring safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOPs (Standard Operating Procedures) are met and appropriately managed when planning projects, developing materials, executing projects, and contracting vendors.
    • Ensuring HCC and legal requirements are fully understood, appropriately managed, and complied with when planning projects, developing materials, executing projects and contracting vendors.
    • Ensuring inspection readiness with respect to personal training compliance, and availability of a recent CV and individualized Job Description.

    Brand Strategy:

    • Global Branding – vison and value proposition: Uses in-depth knowledge of the brand “foot print”, look, feel, identity, essence, to contribute to the process of global branding.  Able to highlight issues to senior management.
    • Segmentation: understands the pros and cons of different segmentation approaches and the interplay between payer, prescriber, and patient segments in developing and executing a marketing plan.
    • Brand positioning: develops, executes, and measures brand-positioning strategies. Success defined by excellence in brand equity.
    • Product, Therapeutic and Disease Condition Knowledge: build brand marketing plans that differentiate products.

    Customer and marketplace focus:

    • Market Dynamics and Evolution: Dissect and understand market dynamics (including social/political) and competitive intelligence and analyze competitor trends. Independently extrapolating data to determine future trends, shaping long term strategy and see linkages across other categories, therapeutic areas, and companies.
    • KOL development and Customer Insight – Current and Future: understand customer insight building on KOL insights both locally and globally, in the therapeutic area—current, future and trends to build a more effective long-term marketing strategy.
    • Geographic, Cultural and Market Insights: understands geographic and cultural needs of different markets to draw meaningful inferences for planning.
    • Patient Insights: Expertise in identifying unique needs of the patient and underlying drivers of motivation to influence senior management to create a strategy that best addresses the patient’s needs.
    • Brand Equity: plan for changes in the relevancy of brand equity dimensions brought about by marketplace changes and new competition.
    • Pricing and Reimbursements: knowledge of systems across the industry/geographies to provide practical value-added suggestions during pricing development, proposals, and negotiations.

    Marketing Execution and Franchise Management:

    • Brand Message Development: understands all phases of the sales process, evaluating brand messaging impact, fully understanding the context from a strategic viewpoint, and making changes for the portfolio consistently across segments for the whole brand, maximizing the effectiveness of marketing mix in line with spend.
    • Targeting: Expertise in making trade-offs between target segments; assessing when change is/isn’t warranted while refining targeting based on analysis.
    • Life Cycle Planning and Management: knowledge of the TA and market and in executing global life cycle pans and evaluating the return on investment. Champions innovative approaches in the development and execution of a competitive life cycle plan. Is a sought-after expert in life cycle planning.
    • Portfolio Management (Strategic Plan): Finds innovative approaches and has excelled at leading the strategic planning process. Coaches and mentor’s others in portfolio/strategic planning.
    • Budgeting: Uses in-depth knowledge of portfolio budget management to deliver against P&L commitment.

    Main Interactions:

    Internal:

    • IBVTLs and local CVT members
    • EMEA Value Optimization Team
    • Other functional area representatives (e.g. MAF, Market Access, Regulatory, BI)
    • Direct team (PSR’s, managers)

    External:

    • Key External Stakeholders (e.g. KOLs, payers, policy-makers) of priority markets
    • External agencies and vendors
    • External business partners (if applicable)

    QUALIFICATIONS:

    Qualification & Experience:

    • A minimum of a bachelor’s degree/diploma is required.
    • A minimum of 5 years of pharma experience is required in which the candidate has demonstrated a strategic mindset with the ability to assimilate complex science and data quickly.
    • Experience working in an environment were taking ownership and driving business initiatives, with a demonstrated ability to work with cross-functional and multicultural team stakeholders.
    • Proven track record of leading teams and ability to influence without authority.
    • Experience in managing brands subject to competition.
    • Experience in these disease areas is an advantage.
    • A self-starter, with a demonstrated ability to interact in a comfortable manner with senior stakeholders and peers across all levels and competencies.
    • Demonstrated ability to work with key external stakeholders.
    • Excellent written and oral communication skills in English
    • This position requires local and international travel.

    Method of Application

    Use the link(s) below to apply on company website.

     

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