Global Risk Management Plan Manager
hace 4 semanas
The Global Risk Management Plan Manager plays a critical role in ensuring the timely preparation, development, and finalization of high-quality and regulatory-compliant Safety Risk Management Plans (RMPs). This position provides support to the Global Product Safety Leader (GPSL) and designated medical writers in managing, coordinating, and reviewing RMPs to ensure they meet Novartis processes and Health Authorities (HA) requirements.
- Support the GPSL in resolving issues related to RMP strategy, preparation, implementation, and overall process.
- Guide the GPSL and key authors to ensure commitments are appropriately worded and reviewed by relevant line functions.
- Coordinate activities across different line units to ensure all required documents are included in RMP annexes and available in the Document Management System.
- Manage logistical aspects related to RMP development, working with authors to ensure content meets Novartis and HA requirements.
- Support the Safety Lead in updating RMPs according to HA requirements and ensuring alignment with Periodic Safety Update Reports (PSUR) and Periodic Benefit Risk Evaluation Reports (PBRER).
- Review RMPs to ensure consistency and regulatory compliance of RMP sections and annexes.
- Track HA feedback and assessment on RMPs, ensuring HA requirements are implemented as required.
- Timely submission and delivery of high-quality RMPs to Health Authorities.
- Ensure RMP documents and annexes are fully compliant with Novartis and Health Authorities technical and format requirements.
The successful candidate will be responsible for:
- Developing and maintaining RMPs in accordance with Novartis processes and HA requirements.
- Collaborating with cross-functional teams to ensure RMPs meet regulatory requirements.
- Providing support to the GPSL and designated medical writers in RMP development and review.
- Ensuring RMPs are submitted to Health Authorities in a timely and high-quality manner.
To be successful in this role, you will need:
- At least 5 years of experience in a pharmaceutical company, preferably in drug safety, clinical research, or regulatory affairs.
- Proven ability to work with large cross-functional teams in complex projects.
- Knowledge of worldwide regulatory requirements for drug registration and clinical drug development.
- Ability to interpret and discuss efficacy and safety data relating to multiple therapeutic areas.
- Solid medical/scientific writing and verbal skills.
Fluent in spoken and written English. Understanding of another major language (e.g., French, German, Spanish) is desirable. A scientific degree is required, and an advanced degree (Masters, PharmD, or PhD) is desirable.
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