Senior Manager QPPV Office PV Alliances
Norgine, United Kingdom
Job Description
Want a 3D Career? Join Norgine.
At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.
We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.
Bring everything about yourself that you’re proud of, whether that’s your passion for making a difference, focus on others’ well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.
In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people’s wellness as much as you do.
Because at Norgine, we transform lives with innovative healthcare solutions.
We have an exciting opportunity for a Senior Manager QPPV Office amp; PV Alliances to join Norgine in Harefield. The person holding this position will report to Director Pharmacovigilance and be a member of the Global Pharmacovigilance team.
The Senior Manager QPPV Office and PV Alliances is responsible for leading and directing the QPPV Office activities and supporting the Director Pharmacovigilance in ensuring that Norgine has an effective, compliant PV system. It plays a key role in ensuring the integration of new partners into the Norgine PV system and ensuring that the appropriate Pharmacovigilance Agreements (PVAs) are implemented with the partners.
If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.
KEY RESPONSIBILITIES amp; ACCOUNTABILITIES
- Provide subject matter expertise during audits / inspections.
- Maintain knowledge of relevant PV legislation, assess impact and take the lead on updating company procedures falling within key areas of responsibility.
- Develop and maintain company procedures supporting pharmacovigilance (PV) within area of responsibility. Includes developing training material and conducting training on the procedures to relevant stakeholders.
- Responsible for the creation and maintenance of PV processes and procedures, documented in company Standard Operating Procedures, Guidelines and User Manuals. Contribute to their effective implementation through targeted training activities.
PV Alliance Activities:
- Direct and be accountable for the Pharmacovigilance Agreement (PVA) activities performed by the Development Outsourced Service Provider.
- Accountable for ensuring quality, review, compliance and database accuracy of all PVAs.
- Act as the Business Development PV lead. Responsible for negotiations and implementation of PVAs with Norgine business partners.
- Mentor members of the GPV team on business alliance activities.
- Lead interactions with Business Development and Alliances for all PV activities. Lead interactions with business partners for all PV activities.
- Responsible for oversight of all Norgine contracts where the partnership involves PV.
- Responsible for generation of the PV Alliance monthly report and provide subject matter expertise in PV business alliance activities.
- Delegate of EU QPPV responsibilities for establishment and maintenance of a PV system for contractual arrangements with partner companies and other Norgine sectors. Delegate of EU QPPV responsibilities for establishment and maintenance of the PSMF.
QPPV Office Activities:
- Direct and be accountable for the Pharmacovigilance System Master File (PSMF) activities performed by the Development Outsourced Service Provider.
- Responsible for creating and maintaining oversight tools to provide data to the QPPV office. Manage the QPPV office function in conjunction with the Director Pharmacovigilance and EU QPPV.
- Responsible for ensuring QPPV office oversight of KPIs from the PV system and ensuring the appropriate actions are taken in the Norgine QMS system and reflected in the PSMF.
- Lead GPV backroom in support of QA inspection backroom and coordinate PV audit/inspection agendas and interviewee participation within GPV.
- Oversight of GPV Corrective Actions and Preventative Actions (CAPA) / deviations to ensure compliance to relevant timelines.
- Responsible for the interaction between the QPPV office, EU QPPV and the Local Qualified Person for Pharmacovigilance (LQPPV).
- Deputise as chair of the QPPV Office for the Director Pharmacovigilance, when required.
- Manage the NorginePVAlliances and QPPVNorgine mailboxes.
Requirements
- Life Science or pharmacy degree with good knowledge of relevant global pharmacovigilance and device requirements for post marketing and development product safety.
- Knowledge of local regulatory authorities PV requirements.
- Proven experience of preparation for and signi