PW-6734 Director, Drug Safety & Pharmacovigilance
Closing Date: 05 Nov 16
Salary (£): Competitive
Benefits: Competitive including share options
This well-funded US biopharma company with a lead asset in Phase III is looking for an experienced PV professional. You will direct and oversee the Drug Safety & PV function ensuring compliance with all applicable legal and regulatory requirements for adverse event reporting & safety management of medicinal products in development as well as preparing the function for post approval work.
AXESS is working exclusively on this position
Newly established in Europe
Reporting to the Vice President of Medical Affairs.
Key, high profile role forming part of an entrepreneurial business and working closely with colleagues in the US
- Sets Corporate direction for drug safety and pharmacovigilance activities for ensuring Corporate compliance with all applicable laws and regulations and as appropriate, local and foreign regulatory reporting requirements, for the processing and reporting of adverse events associated with company sponsored drug products, including both drugs in development and marketed products
- Establishes the Drug Safety & Pharmacovigilance Department direction, standards, and processes for supporting Corporate pharmacovigilance operations
- Oversee the implementation of fit-for-purpose safety tools and systems to support the delivery of the company’s safety and risk management related commitments.
- Oversees and contributes to the daily operations of the Pharmacovigilance department
- Oversees the activities of contract research/service organizations and individuals, contracted to perform drug-safety and pharmacovigilance activities
- Oversees the activities for monitoring adverse event reports for potential drug-safety related issues and provides recommendations when potential issues are identified
- Provides leadership and assists in collaborations with Clinical Development and Medical Affairs and applicable functional specialists to identify, evaluate and manage safety signals.
- Leads the development of signal management, safety surveillance and risk management plans for drug development programs.
- Provides leadership and assists in the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual Report etc).
- Assists in the preparation and revision of company product labeling and RMP / REMS as appropriate.
- Assists in the preparation and review of safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/CTD submissions and other.
- Facilitates and ensures communication with departments that may be involved with receiving, investigating, or reporting AEs
- Collaborates with, and provides pharmacovigilance guidance and support for inter-departmental and/or corporate initiatives
- Collaborates with corporate-partners in order to ensure proper exchange of drug-safety data
- Aligns departmental activities in support of corporate goals, as appropriate
QUALIFICATIONS / EXPERIENCE REQUIRED
- Medical degree or other relevant training and education in the biomedical field with significant experience leadership experience in drug safety and pharmacovigilance in both pre and post marketing experience
- Thorough understanding of the cross functional drug development processes (Clinical operations, Data Management, Biostats, and Regulatory affairs) and context applicable to safety surveillance activities
- Strong working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; European Union (EU) Volume 9A and Volume 10 clinical trials directive; Guideline on Good Pharmacovigilance Practices(GVP) and ICH Guidelines)
- Knowledge of MedDRA terminology and its application
- Experience in the preparation and authoring of pre- and post- aggregate safety reports, RMPs, and RSI
- Experience in managing CRO/vendors
- Must be self-motivated, highly organized, detail-oriented and able to multi-task with delivering high quality work.
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
For a confidential discussion please telephone Christian Simon at AXESS Limited on 020 8560 2300. To apply, please send your CV to email@example.com quoting reference PW-6734.
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AXESS has been operating since 1990
We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development
We match professional candidates to the best permanent, contract and interim roles in the market
Visit us at www.axess.co.uk