Pharmacovigilance Specialist (Maternity Cover - 12 month FTC)

Job Introduction

Why Dechra? 
 
Thank you for checking out our vacancy, we’re delighted you want to learn more about joining Dechra. 

A career at Dechra is different. Sure, we’re a growing global company with a presence in 27 countries but our purpose is simple – to achieve the sustainable improvement of animal health and welfare globally. 

If you want to be part of a team that invests in your future and ensures you have the support to reach your full potential and thrive, please read on.  

The Opportunity 

Dechra is an international specialist veterinary pharmaceuticals products business. Our expertise is in the development, manufacture, sales and marketing of high-quality veterinary products globally.  The primary function of the role is to work within a team of Pharmacovigilance professionals and scientists with expertise across the global portfolio, to deliver Dechra’s goals and ensure that Dechra has a compliant and functional system of pharmacovigilance and risk management in place.

Role Responsibilities 

So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including: 

• AE case report data entry, processing FU, coding. 
• Case review,  Causality assessment and ABON. 
• AE case report data entry – to understand functionality of PV works. 
• Handling CA feedback on cases (eg quality) co ordinating.
• Signal Management: Extracting line listings, annual statements. EU SM – SM justification and statement submission and coaching, dealing with triggered SD activities (as opposed to routine).
•  Monthly monitoring of confirmed signals.
• BRR generation and selected PSUR generation. 
• QRD-9 review of data and regulatory responses.
• Initiate manufacturing investigations (with guidance). 
• LRP/PV PD and defect situations: Handling and responding to straightforward requests. 
• Product defence activities (preparing data packages and response, co-ordinating internal stakeholders).
• Handling high profile/high risk products as Subject Matter Expert, emerging safety issues, communication of safety changes to end user.
• Contribute to SOP and guidance creation. Training new recruits/mentoring and coaching.Assist in preparation for inspections. 
• Progress to act as scribe in internal audits and meetings. 
• Product development and clinical trials support; protocol review and advice, adverse events, representative on PD teams. 
• Promoting organizational values and organizational culture through one's own behaviour and encouraging others' desired behaviours.

The Candidate 

• University degree and/or tertiary degree in veterinary medicine, pharmacy, biochemistry, or related life science disciplines, Vet technician/Vet nurse qualification.
• Experience representing companies and technical matters at Industry working groups. Experience with Audits and inspections
• strong focus on timelines and deadlines; maintains progress and high quality in the face of distractions, always considering increased efficiencies.
• Strategic ability to sort through distractions to find the best route, adept at planning for the outcomes of different scenarios
• Vigilant approach to risk, forward thinking ability to reflect on risks before recommending and adopting changes.
• Resourceful and flexible; adept at managing complex situations with many variables and comfortable with reprioritising.
• Experience within the Pharmaceutical industry