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Karen Shiel
Life Science

+353 1 5079256
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Drug Safety & Pharmacovigilance Senior Director

Reference:KS/HQ00001922 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Drug Safety Officer, Pharmacovigilance

Our client is a Biopharma organisation with offices in Dublin. They are currently seeking a Senior Director, Drug Safety and Pharmacovigilance (DSPV) who will be a senior level employee serving also as Qualified Person for Pharmacovigilance (QPPV) in the EU. The successful person will be responsible for medical review of adverse event reports, aggregate safety reports and signal evaluation. The Senior Director DSPV 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 our clients’ commercial products. As the QPPV, the Senior Director DSPV will communicate new and emerging safety concerns, as well as, benefit risk assessment analyses to the competent authorities. In their role as QPPV, the Senior Director DSPV shall act as the primary and single point of contact to EMA and other national competent authorities.

Role/ Responsibilities:
• Has primary responsibility for evaluation of safety data from marketed products & 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 our clients 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 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, other third parties) are in place and effective
• Reviews and approves Risk Management Plans (RMPs) and other periodic safety updates as required by our clients SOPs
• Assists in the development of risk management strategies around potential drug safety issues
• Represents our clients 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 our client 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 our clients 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

Education/ Experience:
• 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.
• The individual must be permanently and continuously available and reside in the EU/EEA.
• An understanding of standard industry practices pertaining to drug safety and pharmacovigilance, particularly in relation to signal detection and evaluation.
• Collaborate with PV and functional area leaders
• Experience working with safety CRO’s
• Knowledge EU and global drug safety and pharmacovigilance monitoring requirements.
• Demonstrated knowledge of and ability to interpret and apply local drug safety of current EU regulations. and GVP Modules
• Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with regulations
• Experience in data analysis and medical evaluation of safety data
• Hands on experience on regulatory submissions involving safety data
• Proficiency working with a small company with standard desktop and pharmacovigilance computing programs including signal detection and data mining software, and databases many activities outsourced to vendors
• Experience working with senior management in companies and regulators
• Team player with ability to function in a multi-disciplinary environment
• Expertise in internal medicine, endocrine or obesity therapeutics within the pharmaceutical industry. Experience with regulatory inspections & requests
• Some (25%) travel necessary

If you would like further Information you can contact the recruiter directly:

Karen Shiel | Tel: +353 (0) 1 5079256