Safety Data Exchange Agreements Manager
CK Group is recruiting for a Safety Data Exchange Agreements Manager to join a company in the healthcare industry at their site based in Stockley Park on a contract basis for 6 months and has a daily rate of £383.84 Ltd/£296.23 PAYE.
The Company:As a global healthcare company, our client takes on some of the world's biggest healthcare challenges. By delivering a sustainable business, they provide health benefits to patients and consumers, improved shareholder returns as well as supporting wider society. They have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. They are committed to widening access to their products, so more people can benefit, no matter where they live in the world or what they can afford to pay.
The Location: Stockley Park was the UKs first and most successful business park. Situated close to Heathrow Airport in West London, it is home to roles within clinical safety, clinical data, conversion leads, programming, regulatory and more. It's a location that combines excellent transport links with the M4 and M25 motorways and Heathrow Airport a few minutes away. A choice of railway and tube stations, extensive bus networks plus ample parking provides a coordinated transport hub to connect to the Park.
The Role: This role is responsible for co-ordination, end to end evaluation, negotiation, and delivery of Safety Data Exchange Agreements (SDEAs) with Licensing Partners to ensure our client can meet its drug safety and vigilance obligations and ensure Patient Safety. This role is responsible for leading internal projects relevant to SDEAs, change management and making significant contributions to enable or improve compliance with global regulatory requirements for drug safety and vigilance.
- Manage end to end SDEA activities with business partners.
- Work closely with relevant function across company including business development, legal departments, Quality, Medical Affairs to review and approve PV term in commercial agreements where needed.
- Oversee compliance monitoring of SDEAs.
- Oversee the maintenance of the Pharmacovigilance Agreements (PVA) database, SDE website and other storage locations.
- Act as a contact point for audits, partner assessments and inspections.
- Implement problem solving strategies across SDEA teams, such as root cause analysis and CAPA development.
- Identify risks to SDEA processes/groups and implements mitigation strategies.
Your Background: To succeed in this role you will have a strong background in Pharmacovigilance within the pharmaceutical industry. You will have experience of internal/external audits and inspections, a proven ability to interact and influence third parties and stakeholders. You will also have a comprehensive operational understanding of pharmaceutical development and approval processes in major countries, including world-wide pharmacovigilance requirements.
For more information or to apply for this position, please contact Natasha on 01246 457739 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47000 in all correspondence.