Never pay for any CBT, test or assessment as part of any recruitment process. When in doubt, contact us
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare - a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world...
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
Gmail
Yahoomail