Company: Planet Pharma Staffing Limited
Closing Date: 30 Nov 16
Salary (£): Competitive
New Pharmacovigilance Specialist role! Contact me today on - T +44 203868 1009 | M +447398184077 | email@example.com
SUMMARY OF POSITION:
The Pharmacovigilance (PV) Specialist reports to the Pharmacovigilance Country Lead and is responsible for case management activities for Postmarketing and Investigational products in the country/territory. He/She complies with PV processes and regulations, and Merck policies and procedures for his/her country operation. This applies to all relevant safety information. The PV Specialist is qualified to function independently in the processing of Adverse Events.
· Translate and process spontaneous and solicited / clinical trial adverse events reports from their country/territories and enter them into the Global Safety database or forward to a designated data entry center or contractual partners
· Conduct follow-up as required
· Conduct reconciliation of adverse events reports received from other Merck operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable
· File, store, and archive safety-related data
· Comply with PV regulations and Global Safety policies/procedures and when needed propose corrective action
· Participate in individual case safety report compliance activities and takes the necessary corrective actions locally for late reporting within their country/territory
· Identify and communicate potential safety issues
· Complete and document required PV training within required timelines
· Perform other activities as requested by the Pharmacovigilance Country Lead
· Assist in preparation for audits/inspections for their country/territories and participate in the audit and/or inspection
· Fluent in Dutch and English
· Education: HBO/Bachelor, with several years of experience within pharmacy of nursing or WO/Master in the paramedic/medical biology field (can be a starter who is a quick learner)
· Knowledge of medical terminology
· Knowledge of Microsoft Office
· Experience in the pharmaceutical industry is a plus
· Experience with pharmacovigilance is a plus
Skills & Competencies
· Teamplayer: enjoys working together as a team and deliver as a team
· Prioritizing, Planning, Accountability: Accurately scopes out length and difficulty of tasks and projects; prioritizes to meet business objectives and goals; anticipates and adjusts for problems and roadblocks; measures performance against goals and is accountable.
· Learning on the fly – A quick learner, open to change and challenges, looks for learnings in both successes and failures, strives to identify and apply best practices.
· Time management – uses time effectively, works efficiently, is able to prioritize activities, seeks guidance on prioritization when necessary.
10 Greycoat Place, London,
|Tel:||+44 203 868 1000|
|Website:||Visit Our Web Site|
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.