PHARMACOVIGILANCE MANAGER

An opportunity has arisen for a Pharmacovigilance Manager with literature management experience.

Our client is a leading advisory and operational solutions provider to the global life sciences industry. They deliver its services across the full clinical and commercialization continuum and across global markets, collaborating with its biopharmaceutical customers to improve patients’ lives. Through a unique Advise – Build – Operate Model, Kinapse delivers quantifiable business benefits and operational success. Headquartered in the UK, this company has more than 600 staff located in Europe, India and the U.S. 

Role Purpose

A Manager, Pharmacovigilance (PV), will play a key role in executing and managing PV programs for global clients and is expected to lead team(s) of varied size(s) on assignments related to PV.

A program in PV may include processing/review of individual case safety reports, authoring/review of aggregate reports, literature review, drug coding, maintenance of drug dictionary, Medical Dictionary for Regulatory Activities (MedDRA) coding for any of their clients in strict adherence to the Standard Operating Procedures (SOPs) and Work Instructions (WIs) valid at that time and should be available for internal or external audit. The processing of information may include filtering, cleaning, migrating, analysing, reporting, filing or publication of data and information.

• Act as a member of the project management team and oversee successful initiation, execution and completion of PV program(s) for Kinapse global clients.
• Responsible for process implementation and ensuring process compliance.
• Responsible for work allocation, compilation and reporting of the program reports on timely basis.
• Takes a role on contract discussions and negotiations for any assigned programs and brings in the relevant internal parties to ensure a satisfactory conclusion regarding new or extension of contracts.
• May proactively identify business development opportunities and internal business development efforts.
• Leads meetings with client on a regular basis to understand the client’s requirement for a particular program and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints.
• Responsible for the performance management of the program team on an ongoing basis. This may include regular interaction with team members, identifying the areas of improvement and implementing a subsequent training or mentoring plan to ensure all the team members meet or exceed targets with highest level of employee satisfaction.

Skills & Experience

• Significant relevant PV experience either in a pharmaceutical company or with a CRO.
• Literature management experience (managing a literature program or having played a key role in a literature based project).
• Familiarity with literature legislation and implementation.
• Good understanding of clinical development processes including principles of clinical study operations, and ICH-GCP guidelines.
• Experience in managing teams in PV domain.
• A minimum of a graduate degree in life sciences.
• Working knowledge of basic computer applications, e.g. MS Word, PowerPoint.

This pharmaceutical is a fast-growing, values driven company with a supportive team and can offer you a rewarding and challenging career working with smart, ambitious, yet humble professionals. We offer both office and home-based roles, and a competitive salary with a range of benefits including life insurance, health cover, pension and bonus. If you want to be part of a progressive, forward-thinking company and want to make a difference then we want to hear from you.