SDEA Specialist
- Stockley Park, Middlesex (GBR)
- £320 - £370 Per Day
- 4 Months
- Start date: ASAP
- Ref: GSK0JP00082565
- pharmaceutical
- pharmacovigilance
- contract management
- gcp
- databases
- documenting
- communication
- reporting
- archiving
- data analysis
- ms excel
- business development
- management
- search
SDEA Specialist
Uxbridge
4 month contract (Starting May)
Up to £370 per day (Umbrella only)
Responsible for end to end management of Safety Data Exchange Agreements (SDEA) / pharmacovigilance (PV) agreements and provision of PV language for company-wide contracts requiring safety data exchange/PV terms.
The position will work with SDEA Manager:
- Portraying a professional image of GSK, and using appropriate negotiation and influencing skills, to negotiate, review, and write SDEAs/PVAs with external companies, with appropriate guidance, using standard template text when possible.
- Working with local affiliates to provide information to them on SDEAs; collect and collate information from them.
ACCOUNTIBILIITES/RESPONSIBILITIES:
- Works with guidance from SDEA Manager to negotiate, review and write sections of SDEAs using standard template text to ensure GSK can meet PV regulatory obligations world-wide.
- Ensures GSK can meet PV regulatory obligations world-wide via robust SDEAs/PVAs with external companies.
- Conducts routine reviews of SDEAs/PVAs to ensure adherence with global requirements and GSK business practices.
- Trains internal and external stakeholders, as required, to ensure understanding of the terms of the SDEAs/PVAs.
- Liaises with relevant business development and legal departments to ensure proposed PV reporting language is appropriately included in relevant agreements.
- Serves as the point of contact for business partners and internal stakeholders for matters related to SDEA/PVA management.
- Supports timely update of SDEA/PVA information in the PVA database as required.
- Routinly maintains information in PVA database and shared areas documenting information as requested
- Collects, evaluates, analyses and documents information received from local operating company safety departments, with appropriate senior support.
- Runs standard listings from relevant safety and SDEA databases as required.
- Administers document storage and archiving as per GSK relevant policies.
- Interacts with colleagues in Case Processing, SERMs, Legal functions, Business Development, Operating Companies and external companies as necessary.
- Contributes to projects relating to improvements in processes and systems
- Performs other duties as assigned
SKILLS AND EXPERIENCE
- Minimum requirements: BSc or equivalent in life sciences - biomedical sciences, pharmacy or nursing fields preferred,
- Relevant experience in the pharmaceutical industry demonstrating a sound knowledge of pharmacovigilance regulations and safety data exchange agreements
- Extensive experience interacting with third parties (e.g., business partners)
- Business administration and contract management experience - preferred
- Knowledgeable in PV and GCP legislation - preferred
COMPETENCIES:
Technical
- Knowledge of data collection and manipulation – proficiency in MS Excel for data analysis preferred.
- Basic database search skills.
Behavioral
- Good oral and written communication skills.
- Ability to work with tight deadlines while under pressure; demonstrates planning and organizational skills
- Results driven with a sense of urgency that ensures timelines within personal control are met
- Good judgement, common sense and pragmatism
- Functions as a team player
- Customer Focus
- Ability to work independently with only a moderate level of supervision
- Develops self
- Able to build and maintain relationships outside of functional area
- Proactive problem identification
- Solution oriented
Join GSK’s vision to do more, feel better and live longer:
https://www.youtube.com/user/gskvision/
Who will I be working with?
http://www.gsk.com/en-gb/careers/meet-our-people/
