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SDEA Specialist

Employer
Syneos Health
Location
Home/Office Based EU
Salary
Salary Negotiable
Start date
20 Mar 2019
Closing date
19 Apr 2019

Job Details

The SDEA Specialist will support the establishment and maintenance of SDEAs for Syneos Health and for Syneos Health clients.
Job Details:

Your role as an SDEA Specialist would include the following responsibilities: 
•    The SDEA Specialist will be assigned to specific projects and will be overall responsible for ensuring that the client SDEAs are in place and the components included in the SDEAs are updated and according to plan and legislation to ensure compliance.
•    Conducts reviews and manages Client/customer third Party agreements, or draft from scratch or update existing contracts, with respect to pharmacovigilance and the exchange of safety data
•    Maintains contractual overview for the assigned clients.
•    Arranges meetings to overall coordinate, negotiate and finalize the client’s third Party Agreements to ensure finalisation and implementation
•    Involved in internal improvements of the processes covering the post marketing PV system.
•    Serves as a central resource in the QPPV office team which interacts with many different roles located globally - inside and outside of the organisation
•    Helps solve the daily needs in the QPPV office team.  
•    Interacts directly with clients, their third party vendors, including their respective operational teams and legal stakeholders, to collate, update or clarify information for the contracts & agreements including SDEAs as needed
•    Take active part in implementing the SDEA by being responsible for the training and implementation of them after finalization
•    Maintains continuous knowledge and expertise in requirements for safety and pharmacovigilance to ensure SDEA template in Syneos Health is updated as needed.
•    Acting as contact point for business partners, other departments, third party provider(s), authorities and other partners regarding SDEAs.
•    Support and guide relevant client members and other safety team members to deliver relevant safety objectives in relation to the SDEA including but not limited to safety training, inspection readiness and PV system set-up and PSMF deliverables.
•    In collaboration with management as well as PVQA/CQ - be involved in drafting, update and authoring of PV corrective and preventative action plans when related to the SDEA area or other area as defined in the SDEA template. 
•    Provide mentoring and training of global and local PV staff to ensure knowledge sharing and PV qualifications. 
•    Act as SDEA SME and go-to point of contact for local Safety officers in allocated projects when needed


Eligibility/Qualifications/Requirements
The ideal candidate will need the following experience / skills to be considered:
•    BA/BSc in Life Science
•    Extensive Pharmacovigilance and/or regulatory experience within the post marketing area.
•    Adequate theoretical and practical knowledge for the performance of pharmacovigilance activities and processing of contracts
•    Exposure to and knowledge of PV contractual oversight, PSMF and QPPV related activities
•    Good understanding of contractual concepts and terminology
•    Strong organizational skills, ability to adapt in a fast paced and changing environment.  
•    Above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills  
•    Ability to work under pressure to meet tight deadlines
•    Experience in Pharmaceutical Industries, multinational CROs and Research institutes
•    Experience in customer oriented working.

We have a comprehensive benefits package and offer highly competitive remuneration.

If you have the required experience for this position and are eligible to work in the required location then please apply through our online application.

To find out more about our company and search and apply for other open jobs please visit our website https://www.syneoshealth.com/


Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.
Disclaimer: 
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. #LI-LM1
 

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