Safety & PV Specialist I - Based in Sofia Area

Safety & PV Specialist I - Based in Sofia Area

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.  

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know: 

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

 

Job Responsibilities

The role will assist with safety and pharmacovigilance program delivery activities including (but not limited to):

• All aspects of the collection, processing, and reporting of individual cases safety reports (ICSRs);

• Literature screening and review for safety, drug coding, maintenance of drug dictionary, Medical Dictionary for Regulatory Activities (MedDRA) coding;

• Data management activities which includes cleaning and validation of data (xEVMPD product dictionary, manual recoding of substance/product terms arising from ICSR reports, management of duplicate ICSR cases, quality review of ICSRs, Substances, Products, Organizations and Referential (SPOR);

• Identification of Medicinal Products (IDMP) activities and preparation of expedited and periodic safety reports, while adhering to all data privacy guidelines, Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures for clinical trials and/or postmarketing safety programs.

• The processing of information may include filtering, cleaning, migrating, analyzing, reporting, filing or publication of data and information.

Core Responsibilities:

• Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.• Assists in the processing of ICSRs according to Standard Operation Procedures (SOPs) and project/program-specific safety plans as required.• Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.• Enters data into safety database.• Codes events, medical history, concomitant medications, and tests.• Compiles complete narrative summaries.• Identifies information to be queried and follows up until information is obtained and queriesare satisfactorily resolved.• Assists in the generation of timely, consistent, and accurate reporting of expedited reportsin accordance with applicable regulatory requirements.• Maintains safety tracking for assigned activities.• Performs literature screening and review for safety, drug coding, maintenance of drug dictionary,MedDRA coding as required.• Validation and Submission of xEVMPD product records, including appropriate coding of indicationterms using MedDRA.• Manual recoding of un-recoded product and substance terms arises from ICSRs.• Identification and management of duplicate ICSRs.• Activities related to SPOR / IDMP.• Quality review of ICSRs.• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.• Fosters constructive and professional working relationships with all project team members, internal and external.• Participates in audits as required/appropriate.• Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.

QUALIFICATION and REQUIREMENTS

• Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills, and abilities to perform the job.

• 4+ years of experience in ICSR case processing

• Additional and preferred skills: Advanced MedDRA coding training and signal detection management experience

• Safety Database systems and knowledge of medical terminology required.

• Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance

• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet.

• Ability to work independently and in a team environment.

• Excellent communication and interpersonal skills, both written and spoken and good English level

• Good organizational skills with proven ability to prioritize and work on multiple tasks and projects.

• Detail oriented with a high degree of accuracy and ability to meet deadlines.

• Minimal travel may be required (up to 5%).

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

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.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.