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Vacancy details
Vacancy description:
Job Code:
J190820
Job Title:
Director, Pharmacovigilance & Risk Management Writing - Medical Writing
Reporting to the Senior Director, the Director of Pharmacovigilance & Risk Management Report Writing will be responsible for medical writing, management of reference documentation, training and quality control associated with aggregate report writing in pharmacovigilance. Activities include the preparation and expert oversight in the preparation of company Periodic Safety Update Reports, Risk Management Plans, responses to regulatory enquiries and ad hoc safety reports.
Responsibilities
• Support the PV & RM therapeutic area teams in the preparation and updating of Risk Management Plans
• Provide expert oversight and quality control in the preparation of aggregate reports in liaison with the therapeutic area-specific Pharmacovigilance Associates and Physicians accountable for their authorship.
These include periodic safety reports (e.g. PSURs, EU Annual Safety Reports) and ad hoc reports for marketed products
• Training and mentoring for the Global Pharmacovigilance and Risk Management Department in medical writing skills and best practices in association with aggregate report preparation.
• Liaise with PV&RM Operations, Quality and Standards group to develop and maintain associated processes within the company, identifying areas for process improvement as required.
•Represent PV & RM Department in cross-department task forces and establish processes and relationships with other functional areas to ensure needs of PV & RM are met.
• Provide necessary support to the EU Qualified Person for Pharmacovigilance.
Education & Experience Requirements
• Life Science Degree or healthcare professional.
• Post-graduate qualification (PhD, PharmD) in a relevant discipline preferred.
• Minimum of 5 years previous experience working in a similar role with direct experience of aggregate report preparation (PSURs, ASRs, Integrated Summaries of Safety, etc).
• Ability to summarise aggregate safety data and identify the key areas for focus in reports.
Key Skills and Competencies
Experience should include:
• Excellent English medical writing skills gained through a demonstrable record of accomplishment.
• High level of expertise and experience in the preparation of aggregate safety reports and the ability to summarise aggregate data in a clear and concise manner and define key messages.
• Attention to detail and experience in quality control of aggregate reports.
• Previous experience of SOP development and the development of training materials is desirable.
• Solid understanding of the regulations supporting aggregate regulatory reports including ICH guidance, FDA regulations, the E.U. Clinical Trial Directive and Volume 9a.
• Strong mentoring and interpersonal skills and experience in training others in medical writing.
• Self-starter with ability to prioritize, multi-task and work in a matrixed organization.
Other Job Components
Global decision-making and direction setting, including devising of future strategy and the management of complex tasks. It is expected that the incumbent will adapt quickly to changing business and healthcare needs.
The ability to analyse, summarise and group adverse events in a clear and concise manner is an essential part of the role.
Ongoing communication with the global head of safety and receiving clinical advice from safety physicians is a vital part of problem solving. The impact of potential problems may be highly complex and involve active communication in a cross-functional setting to manage various aspects of determining the optimal solution.
Internal and External Contacts
Directs global pharmacovigilance staff on best practice for report writing.
Advises on the application of existing SOPs and guidelines.
Requests data and input from GPV & RM Associates, Physicians and senior managers as required. Will interact with other functions on advisory basis (e.g. CR&D Writing group).
Interactions with regulatory agencies may be required on submission of aggregate reports, variations and at the time of regulatory inspections.
Consults with and co-ordinates with CR&D, Med Affairs, Pharmacoepidemiology & RM consultants when developing PV/RM plans.
Other Requirements
Up to 10% travel may be required. Will be required to travel domestically and internationally to other company sites and CROs or to external meetings
Key Words: Medical Writing Med Writing Pharmacovigilance Writing PSUR ASRs MW PV Director Senior Manager Management Research and Development Biotechnology Pharmaceutical Hampshire Berkshire Middlesex South South East Wiltshire Surrey UK Anywhere Relocatable
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