Career Opportunities at Roche

The Position

• As the Technician in Reagent Manufacturing, you perform production and testing, including production support duties for Operations ensuring quality of production and lab testing is completed by the department.

Your challenge

• Perform a variety of duties relating to production operations. Follows departmental work instructions, SOP’s, OSHA safety regulations and cGMPs to perform assigned tasks.
• Monitor and oversee lab supply inventory, generate expense purchase requisitions, if applicable, input production data and other work-output data into appropriate network (e.g. SAP / LIMS) and maintain documentation in accordance with established procedures.
• Maintain stock rooms and laboratories or work areas properly stocked with daily supplies to include the scheduling of repairs and preventative maintenance as necessary and report malfunctions to supervisor.
• Monitor lab supply inventory, generate expense purchase requisitions, if applicable, input production data and other work-output data into appropriate network (e.g. SAP / LIMS) and maintain documentation in accordance with established procedures.
• Depending upon area of assignment or primary focus, may perform various manufacturing and testing duties in addition to maintaining departmental stock rooms, log books, preparing buffers as needed/required which may also include, performing direct manufacturing activities such as bulk formulation, filling, sub-assembly and sample testing.
• Interface with internal groups to assure laboratory equipment maintenance, calibration and documents conform to established practices.
• Manages schedules, workload and establishes priorities using inputs from business requirements, SAP, and/or internal customer needs.

Who you are

Formal Training/Education

• National diploma or equivalent combination of education and applicable work experience (required)
• Bachelor’s degree or equivalent combination of education and applicable work experience (preferred)

Experience

• 0-2 Years General laboratory experience. Basic GMP Knowledge

Knowledge, Skills and Abilities

• Demonstrated ability to follow Standard Operating Procedures (SOP), Manufacturing Instructions (MI) and Work Instructions (WI) documents.
• Demonstrated competency in reading and completing charts, forms, and other documents.
• Ability to use personal computer with basic word-processing, spreadsheet and inventory management applications
• Good written and verbal communication skills
• Ability to perform in an aseptic environment - wear personal protective equipment, such as eye, foot, lab coat, mask, gowning coveralls etc.

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Your Primary Responsibilities and Accountabilities ;

• Ensures collection, reporting and handling of safety information associated with Roche products is performed according to global Roche and local regulatory requirements within the assigned PV hub coverage areas. 
• Maintains oversight of safety risk management and performs all other PV activities where applicable. 
• Proactively manages workload to ensure regulatory timelines are met. 
• Strives for excellence in the area of assigned responsibilities and simplification of the processes where possible 
• Works in close collaboration with PV Hub process, country champions and Affiliate Patient Safety partners to maintain compliance of executed activities 
• Ensure records are managed as per Coremap requirements 

Key Challenges

Maintain a local PV system in context with and as defined in the wider global Roche PV system

• Ensure appropriate documentation of PV related information and activities.
• Ensure business continuity of critical PV systems, processes, and activities.
• Ensure PV inspection readiness at all times.

Pharmacovigilance System Master File (PSMF)

• Where PV Hub is required to provide information and data relevant to the global Roche PSMF, or for other global PV oversight or management purposes, ensure the data is current, accurate, complete, and provided in a timely manner.
• Where a separate local PSMF is required, ensure consistency with global Roche processes for local PSMF or PSSF. (where applicable).

Individual Case Safety Reports (ICSR)

• Ensure oversight and management of ICSRs from all sources in a timely manner, including appropriate follow up, reporting, and documentation.(where applicable).
• The above also applies to external third parties acting on behalf of Roche.

 Management of aggregate reports

• Ensure relevant information is provided to global functions for the preparation of aggregate reports (e.g., PSUR), as required.

Risk management and safety communication

• You will Contribute to the development of local Risk Management Plans (RMP) and ensure oversight of RMP implementation and safety communication, including adequate documentation of risk minimization activities, dissemination of communication and activities , decisions, and actions taken as applicable. (where applicable).

Oversight of studies, programs, and other business activities

• Ensure appropriate safety reporting and oversight processes are in place for studies (including interventional clinical trials, NIS, PASS, PAES), Market Research and Patient Support Programs (MAPs), pre-approval and post-trial access programs (including 'compassionate use'), and all other business activities with implications for PV compliance.
• Ensure oversight of external third parties acting on behalf of Roche (e.g., service providers, CROs) or acting as Roche business partners (e.g., distribution, licensing, or development partners). This also includes written documentation of roles and responsibilities relating to PV compliance, and oversight of adherence to agreed roles and responsibilities.

Who You Are as an Ideal Candidate

Professional and Technical Requirements:

Education/Qualifications

• Minimum: Health Care Professional Degree (e.g. Medical Degree, Pharmacist,) or Life Science Degree
• (e.g. BSc Biology, BSc Neuroscience, etc.)
• At least 4 years experience in Pharmacovigilance

Recommended Experience, Skills, Knowledge:

• Appropriate experience in Drug Safety/Pharmacovigilance, preferably 1-2 years
• Knowledge of global Pharmacovigilance regulatory requirements
• Ability to evaluate, analyze and interpret data, and draw conclusions, independently
• Strong organization skills, detail oriented, ability to adapt to change
• Effective team player, demonstrating initiative and accountability
• Good interpersonal skills, builds strong sustainable and collaborative relationships with internal and external stakeholders, as well as effective collaboration with functional groups and management
• Good communication skills, both written and verbal
• Identify improvement areas and provide creative problem solving in a complex process-focused environment
• Ability to work under pressure and convey a sense of urgency
• Ability to work across cultures, including in a virtual environment
• Proven ability to demonstrate Roche Values
• Computer literate

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Main Responsibilities

Healthcare Consulting Sustainability  

• To manage the preparation of the offers for strategic consultancy services towards the customers, including for projects which may span multiple countries, by providing the brief, reviewing the draft or drafting proposals and providing input as required
• To create mutually beneficial business partnerships/arrangements with customers, 3rd party suppliers, and/or additional healthcare actors , including PanAfrican region level and/or global health level stakeholders, by identifying, researching, analyzing and making recommendations and negotiating strategic alliances in collaboration with the Africa network as required
• To drive new business by identifying, analyzing and comparing alternative opportunities for entering new markets and adopting new strategic consulting services as required
• To champion new and transformative approaches and new business models within the operating context of the Roche Africa Network and EMEA LATAM Region  with a focus on developing transformative approaches to deliver more value for healthcare systems. These might include outcomesbased and valuebased approaches amongst other new business models.

Strategic Consultancy Delivery 

• To analyse and improve healthcare policy and clinical processes, gathering the related data necessary for the development of business cases for decisionmaking from healthcare management       
• To participate in the development of strategies, contracts, creation of projects and providing specialized consulting services in support of customer and PanAfrican stakeholder relationships       
• To oversee multicountry project implementation by leading strategic consulting projects and coaching the customer team to reach their goals with tangible outcomes and costbenefit analysis as required
• To resolve complex customer problems by looking beyond existing methodologies and own discipline to define and facilitate implementation of solutions as required, 

Stakeholder Relations

• To navigate the complex stakeholder management of multicountry projects and balance the project operational needs with the client’s political position, observing all necessary protocols and diplomacy requirements
• To help maintain the organization’s ongoing relationships with Health Authorities, Industry and Trade Associations and Allied organizations and stakeholders across Africa and within the global health landscape as necessary by continuously engaging them and addressing their queries as required in conjunction with other members of the Healthcare Transformation Team and other internal functions like Medical Affairs and Marketing, Global Access Program Network, One Roche Policy & Partnerships team and other networks as appropriate., 
• To contribute meaningfully in the International RHC community by regularly attending and contributing content to meetings and initiatives and by participating on international projects

Financial Management

• To monitor finance and ROI for Roche of strategic projects by understanding financial statements and reports and connecting activities with the outcomes in the financial statements and working and interacting closely with the customer/stakeholder financial functions as required.

Qualifications and Experience

• Bachelors degree in Science, Business or Commercial fields.
• Qualification in RHC Strategic Consulting
• 1 to 3 years in Strategic Thinking or Strategic Management roles.
• 35 years experience in sales, marketing or similar
• French and English required, Arabic and/or Portuguese advantageous
• Must have knowledge of Business Development, Relevant Product Knowledge, Commercial Knowledge

Recommended Skills and Abilities

• Achieving results
• Strategic agility
• Networking and Relationship management
• Accountability
• Communication (verbal and written)
• Inspiring and influencing
• Situational responsiveness
• Innovation
• Ability to travel nationally and internationally