Company: Thornshaw Recruitment
Closing Date: 18 Feb 17
Salary (£): Negotiable
Our client, a leading US biotech company have a new vacancy for a Sr. Director, Drug Safety & Pharmacovigilance M.D - Fantastic opportunity to join their new European headquarters. This role may be based in the UK or Dublin.
2017 - New year, new career - Our client, a leading US biotech company have a new vacancy for a Sr. Director, Drug Safety & Pharmacovigilance M.D - Fantastic opportunity to join their new European headquarters. This role may be based in the UK or Dublin.
Summary: The Senior Director, Drug Safety and Pharmacovigilance (DSPV) will be a senior level employee serving also as the company’s Qualified Person for Pharmacovigilance (QPPV) in the EU. You will be a key member of the global drug safety and pharmacovigilance team, participating fully in pharmacovigilance activities, including medical review of adverse event reports, aggregate safety reports, signal evaluation, risk mitigation, and risk communication measures for commercial products.
Essential Duties and Responsibilities:
• You will have primary responsibility for evaluation of safety data from marketed products and clinical studies. Evaluates or reviews individual case safety reports from all sources
• Collaborates with internal and external stakeholders (including business partners) to ensure adequate safety monitoring practices are implemented and followed
• Ensures that Pharmacovigilance System Master File (PSMF) is in place, accurate and up to date
• Researches best practices in the industry involving drug safety and evaluates and oversees their implementation in the organization
• Oversees compliance with applicable regulations, standard operating procedures and Working Documents related to pharmacovigilance. Ensures that PV training is done in the drug safety/PV department as well as everywhere else in the company (e.g. vendors, third parties) where safety data matters may arise
• Reviews metrics and key performance indicators on expedited and aggregate reporting and other key PV operational functions
• Makes sure that necessary Quality Control (QC) and Quality Assurance (QA) mechanisms are in place to maintain compliance
• In collaboration with Company Quality Assurance, ensures that a quality management system is in place which includes audits, inspections and Corrective Action, Preventive Action plans (CAPAs), as needed
• Ensure that commitments to the health authorities regarding safety are kept
• Ensure that written agreements with other companies regarding safety (including business partners, vendors, and other third parties) are in place and effective
• Reviews and approves Risk Management Plans (RMPs) and other periodic safety updates as required by Company SOPs
• Assists in the development of risk management strategies around potential drug safety issues
• Represents the Company Drug Safety function at meetings with regulatory authorities and third parties such as licensing or co-development partners, consultants, opinion leaders. Responds to safety related inquiries from regulatory authorities and internal and external partners
• Provides medical input in regulatory documents: INDs, NDAs, PADERs, PBRERs, PSURs; Annual Safety Reports, Core Data Sheets, Investigator Brochures, Clinical Study Reports, Clinical Summaries and Clinical Overviews (benefit-risk evaluation).
• In collaboration with clinical development, biostatistics, and regulatory staff, defines strategies for safety data collection, evaluation and reporting for products in clinical development.
• Ensures that signal detection and signal management mechanisms are in place and participates in signal evaluation
• Ensures that all suspected adverse drug reaction received by the company are collected, collated and accessible at one or more points in the EU
• Ensures that ICSRs, Post-Authorization Safety Study (PASS) cases, PSURs and any other safety commitments are reported appropriately to the competent authorities (CAs)
• Ensures the continuing evaluation of the benefit/risk analyses of all products
• Maintains an overview of the safety profiles and any emerging safety issues on company products
• Ensures full documentation of all QPPV procedures and activities
• Implements mechanisms for the QPPV to be kept informed of emerging safety and risk-benefit issues
• M.D. with clinical background preferable
• At least 5 years’ experience in Pharmaceutical Industry Drug Safety function or related function
• Prior QPPV experience
• 10 years of experience in the pharmaceutical industry, preferably most of that in drug safety and pharmacovigilance.
• The candidate must be appropriately qualified in the theoretical and practical knowledge of pharmacovigilance and experienced in all areas of pharmacovigilance.
For more information - Contact Tina at +353 1 2784671 or email in confidence to email@example.com. WWW.thornshaw.com
Barton House 6 Old Dublin Road Stillorgan Co. Dublin
|Tel:||00 353 (1) 278 4671|
|Fax:||00 353 (1) 278 4672|
|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.