PV Deputy LPPV

Job description

Job Description

Sandoz, a global leader in the rapidly growing generics industry, is a company in which doctors, pharmacists and patients worldwide have placed their trust for more than 100 years.

With our 26 000-plus employees in more than 140 countries, we save and improve lives by developing, producing and distributing high-quality, affordable pharmaceuticals. Choosing Sandoz is always 'a healthy decision'.

Role Profile:

Provide direct support to ensure full compliance of all Sandoz Pharmacovigilance & Clinical Safety operations on local level. To fully implement locally Sandoz Global Pharmacovigilance & Clinical Safety (GPV&CS) operational processes (GOPs) in ensuring compliance with internal Sandoz global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance regarding Sandoz marketed and investigational products.

To assist and deputise for the local Qualified Person for Pharmacovigilance (LPPV) in the UK.

Major Accountabilities:

• Manage collection, processing, documentation, reporting and follow-up of all ad-verse event (AE) reports and adverse drug reactions (ADR) for all Sandoz products approved in the country(s) of responsibility from clinical trials, post-marketing studies (PMS), Spontaneous Reports (SR), registries, commercial programs, etc.
• Ensure recording and tracking of receipts/submissions/distributions of Individual Case Safety Reports (ICSR), Serious Adverse Events (SAEs), Investigator Notifi-cations (IN), Periodic Safety Report Updates (PSUR) and Annual Safety Reports (ASR) and ensure reporting/submission/distribution of safety re-ports/updates/information (e.g. ICSR, SAE, IN, PSUR ASR, changes in risk benefit) to local Health Authorities (HA) according to regulatory requirements.
• Work with other local/global PV associates to ensure accurate processing of safety data.
• Interact and exchange relevant safety information with local HA, PV associates, other functional groups and third party contractor, if applicable.
• Maintain current awareness of national pharmacovigilance regulations and provide update to GPV&CS.
• When required, create, implement and update local procedures to ensure com-pliance with GPV&CS procedures and national requirements.
• If applicable, coordinate execution/implementation of Risk Management Plans/Commitments and ensure related documentation.
• Review marketing program proposals regarding correct terminology, content and establishment of necessary flow of information and control on collection and re-porting of adverse event information. Train responsible vendor associates.
• Assure reconciliation is performed with other departments (e.g. Medical Infor-mation, Call Center, Quality Assurance and third party contractor, if applicable) for potential ADRs/AEs resulting from medical inquiries and quality related complaints.
• Management and maintenance all local relevant PV databases.
• Ensure timely preparation and submission of KPI reports on ADR/AE and PSUR reporting including identification of root cause(s) for internal and external late reporting inclusive of development and implementation of corrective/preventive action(s) as needed.
• When required develop and update training materials for pharmacovigilance and ensure training of associates on relevant PV procedures and in ADR/AE reporting, of e.g. field force, switch board/reception, legal department/representative and third party contractor, if applicable.
• Ensure clear, correct and complete documentation of all training.
• Ensure support of audits and HA inspections and execution of respective action plans.
• Manage and maintain efficient PV filing and archiving system.
• Ensure appropriate agreements are in place for local licensor or licensee to comply with all requirements for reporting ADRs/AEs.
• Assist in all case management activities for individual case safety reports (ICSRs) safety case reports from clinical trials, post marketing (including literature) sources and contractual partner sources onto the global safety database in accordance with internal procedures to maintain
• Submit PSURs within the specified timeframes
• Maintaining and harmonising Pharmacovigilance systems including the global safety database and streamlining operational processes both locally and globally.
• Respond to Medical Information enquiries received from Sandoz UK Service pro-vider (Professional Information, PI) as well as external and internal enquiries.
• Recognising and forwarding Product Quality complaints to the QA Department and performing monthly reconciliations.
• Perform and manage reconciliation process of SAE's for assigned Pharmacovigi-lance Date Exchange Agreements in a timely fashion.
• Coordination and assist departmental training and contracted out services to achieve company objectives.
• Assist with the production of Pharmacovigilance Agreements with external busi-ness partners.
• Provide assistance to the LPPV where delegated including deputizing when ap-propriate.
• Support the life-cycle management of Sandoz UK products through the Launch (LAD), Post approval notification (PAN), Pruning and Discontinuation processes.

Desired profile

Education:

• Graduate in Medical Science, pharmacy, biology, biochemistry or similar discipline.

Experience:

• 3-4 years of experience with pharmacovigilance and knowledge of national pharmacovigilance and drug safety regulations in the UK.