To ensure pharmacovigilance (PV) and Medical Information (MI) activities performed by the client are completed in an efficient and effective manner, and in compliance with company procedures, relevant legislation and regulations to safeguard the interests of patients and Healthcare Professionals (HCPs) and the business interests of the client.
- Ensures oversight, and maintenance of the internal PV system, oversees and inputs into the PV activities as performed by the 3rd party PV provider.
- Ensures the PV Quality Assurance system remains up to date and complies with relevant legal requirements, regulatory and ethical standards and the clients SOPs.
- Organises and reviews audit schedule and supports internal inspection readiness.
- Ensures out of hours PV cover
- Provides input to business development to conduct PV Due Diligence before marketing approval.
- Provides timely support to facilitate Marketing Authorizations being obtained, in the relevant territories.
- Conducts case reconciliation with concerned departments or business partners.
- Acts as a back-up for Medical Information for MI enquiry handling so that all enquiries and AEs are handled and reported within SOP timelines.
- Ensures that CH employees are suitably trained and made aware of PV.
- Manage Periodic Safety Update Reports (PSURs) schedule and ensure timely submission to regulatory authorities.
- Ensures Global and local literature searches performed accordingly.
- Oversee Safety Surveillance tasks, ensure signal detection activities are carried out for products.
- Oversees Risk Management Plans for CH products and manage risk minimisation measures as per requirements.
- Answers MI telephone, email, and letter enquiries from HCPs, ORDMS, HCOs, patients, public, and other organisations in line with industry standards and code of practice
Education and Required Experience:
- Educated to degree level in a science degree or equivalent
- Significant previous experience within Pharmacovigilance; knowledge of regulatory environment and PV systems
- Strong organization and prioritisation skills; ability to multitask
- Excellent verbal communication skills/positive telephone manner
- Excellent time management skills with the ability to plan and prioritise workload
- Excellent attention to detail
- Ability to critically appraise scientific/clinical data
- Excellent analytical and problem-solving skills; effectively applies technical knowledge to solve non-routine problems
- Ability to work independently and collaboratively
- Self-motivated to maintain high efficiency and productivity levels
- Good IT skills
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@achieva.co.uk
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- Agency: Achieva Group Limited
- Reference: BH-34399
Website: Achieva Group Limited
- Posted: 21st February 2023
- Expires: 21st March 2023
