Ipv Affairs Manager

3 semanas atrás

Lisboa, Portugal Johnson & Johnson Tempo inteiro

We’re Janssen, the pharmaceutical company of Johnson & Johnson

At Janssen EMEA, we’re dedicated to tackling some of the most important public health issues across Europe, the Middle East, and Africa.

We are uniquely positioned to benefit from the region’s world-leading scientific and political organizations, along with its diverse mix of countries.

We have 30 local offices each with its own unique challenges, but all united by one shared vision: a future where the disease is a thing of the past.

For our International Pharmacovigilance team, we are hiring an IPV Affairs Manager

The International Pharmacovigilance (IPV) Affairs Manager will support the Global IPV Affairs Team in all IPV operations and compliance tasks related to the vigilance of the J&J product portfolio. They will work in close partnership with IPV Regional Heads, Local Safety Teams, and Case Management Teams to ensure adequate centralization of activities enabling process optimization and growing efficiencies.

They will ensure a consistent operations approach across all regions and will lead or contribute to global or regional multi-disciplinary projects and will support shaping strategies for the projects assigned and areas of expertise. For areas under responsibility, they will act as Subject Matter Experts (SME) for the IPV organization, driving and/or supporting the finding of the most suitable and efficient solutions during discussions with different cross-functional teams.

They will be involved in different operational activities in IPV Affairs, but are mainly responsible for supporting the IPV organization to maintain oversight of PV regulatory changes and monitor local implementation. Moreover, it will have the opportunity to shape the operational framework and look for efficient solutions that can lead to a more proactive approach to compliance by focusing on PV regulatory intelligence and risk identification.

**Major responsibilities**:

- Work in close partnership with LSO, IPV Regional Heads, and GMS/OCMS PV Safety Policy teams to maintain oversight of changes in PV regulatory requirements, support review, impact assessment, and local implementation of PV legislation.
- Oversee timely implementation of activities under IPV responsibility mainly for PVRR topics to ensure compliance with PV System Quality Standards and processes.
- Act as IPV SME for PV regulation with regional and global impact, involving the right functions within IPV, coordinating impact assessment for the organization and actions needed.
- For areas under responsibility drive and/or support finding the most suitable and efficient solutions during discussions with different cross-functional teams.
- Develop effective working relationships with collaborators both internally and externally to represent IPV Affairs and gain insights into areas impacting IPV projects and work-related areas of expertise.
- Support IPV in building and maintaining inspection readiness for all IPV-related activities under their responsibility.
- Lead or participate in global or regional functional projects and shape and influence strategies and deliverables for projects assigned in the function/department.

**Qualifications**:
**Qualifications**:

- Pharmaceutical or science degree with experience in the pharmaceutical industry
- Minimum of 3 years experience in a Pharmacovigilance related position
- Experience in Medical Devices and/or GCP legislation will be valued
- In-depth understanding of vigilance systems and processes; knowledge of or experience with International Pharmacovigilance or Safety Policy and compliance regulations is an advantage for this role
- Proven management capability with the ability to simplify complex workflows and simultaneously manage critical issues in a complex and changing internal and external environment
- Excellent negotiation skills and influencing internal and external partner
- Excellent social, interpersonal, oral, and written communication & presentation skills and fluency in English
- Proven Project Management -task-oriented experience including customer management
- Proven ability to build new and maintain strong open relationships both within an organization and with external customers and Authorities
- Able to work effectively with different cultures and instill a culture of diversity and inclusion
- Ability to connect in a complex and geographically widespread organization and ability to drive things

Flex-office-based role as per local HR policy from any Janssen office in EMEA.

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