Ipv Affairs Manager

Há 3 dias

Lisboa, Portugal Johnson & Johnson Family of Companies Tempo inteiro

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. She/he will work in close partnership with IPV Regional Heads, Local Safety Teams and Case Management Team to ensure adequate centralization of activities enabling process optimization and growing efficiencies.

She/ he 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, she/he will act as Subject Matter Expert (SME) for the IPV organization, drive and/or support on finding most suitable and efficient solutions during discussions with different cross functional teams.

She/he will be joining the Central PV Regulatory Team in IPV Affairs and play an active role on supporting the IPV organization to maintain oversight on 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 on 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 for areas of expertise.
- Support IPV in building and maintaining inspection readiness for all IPV related activities under her/his 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**

**Requirements**:

- Pharmaceutical or science degree with experience in pharmaceutical industry and experience in Pharmacovigilance
- Minimum of 3-year experience in a Pharmacovigilance related position
- 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 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, organizational, oral and written communication & presentation skills and fluency in English
- Proven Project Management -task oriented experience including stakeholder management
- Proven ability to create new and maintain strong open relationships both within an organization and with external stakeholders and Authorities
- Proficiency in Microsoft Excel, Word, Outlook, and PowerPoint is required.
- Efficient, flexible, and dynamic team player
- 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
- Ability to operate autonomously without continuous direct supervision

**_For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo._**

**_We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences_**

**_That is why we in Portugal are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are._**

**_Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”_**

**Primary Location**
Portugal-Lisbon-Lisbon
- **Other Locations**
Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-Belgium
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