Job Description
Pharmacovigilance - Manager Job Introduction Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra!
Dechra is 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 .
Our values are embedded within our culture and thrive within our family of almost 3000 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
The Opportunity 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 .
Main Responsibilities So, what will you be doing? This role has a broad and varied scope and the successful candidate will have responsibility for duties including:
PSURS Adverse Event Processing - AE case report processing.
- 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.
- AE submissions according to guidance.
Benefit Risk Assessments - BRR generation and selected PSUR generation
Product Maintenance and Defence - Initiate manufacturing investigations (with guidance).
- LRP/PV PD and defect situations: Handling and responding to straightforward requests.
- Providing PV data under supervision for internal partners.
- Screen routine enquiry checks.
- Providing PV data under supervision for internal partners.
- Product defence activities (preparing data packages and response, coordinating internal stakeholders).
- Handling high profile/high risk products as Subject Matter Expert, emerging safety issues, communication of safety changes to end user
SOP Maintenance & Training - Contribute to SOP and guidance creation.
- Management of LRP network, trainings etc under supervision.
- Contribute to SOP and guidance creation.
- Training new recruits/mentoring and coaching
Additional Information - Promoting organizational values and organizational culture through one's own behaviour and encouraging others' desired behaviours
Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We're particularly excited to hear from those who have/are:
- Bachelor of Science, Biological Sciences Doctor of Veterinary Medicine
- Resourceful and flexible; adept at managing complex situations with many variables, comfortable with reprioritising.
- Disciplined; 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
- AHI-Signal Management Taskforce
As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements . We offer a generous employer 401k match and an other incentives for long-term financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work .
Job Tags
Full time, Worldwide, Flexible hours,