Job Description

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding peoples varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.The PositionA healthier future. Its what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.
Creating a world where we all have more time with the people we love.
Thats what makes us Roche.The OpportunityRoche Pharma in Midrand is seeking a Pharmacovigilance (PV) Hub Partner who will be responsible for supporting PV activities within the hub coverage areas to ensure PV activities are completed consistently in a timely manner in accordance with internal processes and local and international regulatory requirements.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 ChallengesI. 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.

II. 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).

III. 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.

IV. Management of aggregate reports

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

V. 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).

VI. 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 CandidateProfessional and Technical Requirements:
Education/QualificationsMinimum: 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 PharmacovigilanceRecommended 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

Highly Weighted Competencies:

• Technical and Business Expertise, Communication, Teamwork and Collaboration, Achieving Results

Other: Fluent in English - verbal and writtenWho we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, weve become one of the worlds leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Roche is an Equal Opportunity Employer.

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