The role will use technical expertise to:
- Support the setting of Pharmacovigilance and Product Quality Complaint cases in the UK
- Support the Pharmacovigilance Manager in maintaining, developing and implementing Pharmacovigilance compliance procedures.
Priority is given to Pharmacovigilance case setting which must be completed to a high standard within short deadlines. This involves working with the technical and veterinary teams who gather the case information, to ensure that information gained is sufficient and to a high clinical standard to allow each Pharmacovigilance case to be fully assessed and coded within PV Works.
The role will also assist the current team of Pharmacovigilance Officers by giving technical support.
The role will assist the Pharmacovigilance Manager with the maintenance, development and implementation of Pharmacovigilance compliance procedures in line with internal and external guidance.
The successful candidate will be a vet, member of the RCVS ( Royal College of Veterinary Surgeons)
MAJOR ACTIVITIES AND RESPONSIBILITIES:
- To enter data for pharmacovigilance cases in the appropriate system within the deadlines.
- To assess cases for VEDRA coding and final causality, with explanation of findings.
- Apply technical knowledge to improve pharmacovigilance case technical content, case quality and consistency
- To liaise with Competent Authorities as required
- To liaise with Vet advisers and the Technical Product Support Group to ensure accurate case data is available and to reconcile anomalies
- To work with Global colleagues to understand the Pharmacovigilance requirements for different products.
- Product Quality Complaints setting in PV Works
- To assist the Pharmacovigilance Manager with maintaining, developing and implementing Pharmacovigilance compliance procedures.
- To provide backup to the Pharmacovigilance manager and PQC DPOC to ensure compliance with procedure and deadlines as required.
- To give advice/training to Commercial, Pharmacovigilance and Technical product Support Group as required.
Major challenges of the role are:
- To source accurate data from practices and use technical knowledge to assess this when case setting.
- To liaise with global colleagues to discuss pharmacovigilance cases.
- To assess operational protocols and implement improvements.
- To ensure all cases are reported in the required timescale
- To prioritize work loads
Employee Status:
- Employee Status:
- RegularRelocation:
- No relocationVISA Sponsorship:
- NoTravel Requirements:
- No Travel RequiredFlexible Work Arrangements:
- Not ApplicableShift:Not IndicatedValid Driving License:
- NoHazardous Material(s)
Adverse Event Report, Compliance Monitoring, Data Analysis, Decision Making, Drug Safety Surveillance, Pharmaceutical Regulatory Compliance, Pharmacovigilance, Regulatory Compliance, Regulatory Reporting, Risk Management, Veterinary Products, Veterinary ServicesPreferred Skills
#J-18808-Ljbffr
Pharmacovigilance Veterinary Officer in Aylesbury employer: MSD
MSD is an exceptional employer that champions inclusivity and diversity, making it a great place for individuals looking to thrive in a supportive environment. With a strong focus on employee growth and development, particularly in the dynamic field of animal health, team members benefit from collaborative partnerships and innovative sales strategies tailored to the unique needs of farmers in Wales. The company fosters a culture of high performance while ensuring that employees feel valued and empowered to make a meaningful impact in their roles.
