Head of Regulatory Affairs - Pharmacovigilance
Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra Pharmaceuticals PLC.
Dechra are a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.
Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business
- Effectively manage the global Centralized Pharmacovigilance (PV) team in delivery of all PV activities ensuring Dechra’s compliance with various regulatory requirements around the globe.
- Collaborate with business partners to effectively harmonise the centralisation of PV activities from international territories.
- Maintain and optimise Dechra’s Pharmacovigilance system to ensure that data are collected from all territories, the Benefit: risk balance of Dechra’s product portfolio is monitored, analysed for signal detection and end-users have access to informative product information.
- Ensure appropriate escalation and actions agreed where signals are detected (Global Safety Council)
- Oversee the growth and adaption of Dechra’s PV processes and systems in-line with developing business needs and in response to changes in global regulatory framework.
- Drive improvement and expansion through working cross-functionally within Dechra to develop, seek alignment on and implement working practices that provide an effective and robust PV system.
- Collaborate with external business partners to ensure that PV data relating to Dechra’s portfolio is collected from all territories and to ensure that Dechra complies with contracted PV obligations as a Distributor.
- Be the primary interface between Senior Management and the PV team, providing transparent communication of key messages and updates in a balanced manner to support Dechra’s business goals.
- To actively promote the importance of robust PV compliance in all territories and at all levels in the context of added value.
So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:
- Responsible for the planning, scheduling and monitoring of the PV team business objectives for areas of activity.
- Manage all mandatory and desirable PV activities within allocated resources and develop convincing, robust and cost-effective solutions where changes are required.
- Manage the PV budget for areas of activity.
- Effectively manage and grow a diverse PV team while demonstrating Dechra values.
- Participation in activities of other departments in jobs related to the scope of PV work.
- Oversee and coordinate / contribute to, the preparation of documentation needed for regulatory submissions globally (variations / renewals / supplements / reports).
- Comply with global privacy regulations (GDPR) in the distribution and storage of PV documentation.
- Active monitoring of legislation and regulatory situation in target markets.
- Schedule and conduct regular and adequate external and internal site-based PV audits.
- Writing PV expert reports to support Dechra’s submissions.
- Promoting organisational values and culture through one's own behaviour and encouraging others' desired behaviours.
- Communication of PV team activities to RA management, peers and to the EU, NA and International sales groups.
- Provide expert input into PV elements of distributor contracts and other partnership relationships (PV agreements) and collaborate with Dechra legal on these to drive compliance.
- Coordinating analysis and strategic use of signal detection to maintain and develop balanced and appropriate labeling for Dechra’s regulated products.
The Ideal Candidate
Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We’re particularly keen to hear from those who have/are:
- Ensure that the Central PV team targets are accurately defined, monitored, communicated and met.
- Ensure that International PV targets are defined, monitored and met and centralise these where it is beneficial to do so.
- Proactively seek opportunities for, and where agreed, and deliver PV team process improvement.
- Develop PV operational and data analysis skills and expertise, including signal detection within the PV team.
- Communicate effectively with all business partners on the drivers behind effective PV systems and controls and demonstrate how they add value to Dechra.
- Communicate effectively with RA management and cross functionally regarding current and emerging PV risks and opportunities.
- Ensure pro-active PV participation in Industry working groups to promote a practical PV landscape suitable for Dechra’s needs.
About the Company
All applications received are reviewed by our internal talent acquisition team and we will get in touch if your skills and experience match what we’re looking for. Should you not hear back from us within 28 days please don’t be too disappointed – we may keep your CV on our database for any future vacancies which may be suitable and we encourage you to keep an eye on our careers site. For any questions or queries, please contact us at email@example.com
Dechra Pharmaceuticals PLC