Safety & PV Specialist II (Literature Review)

Description

Safety & PV Specialist II (Literature Review)

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

JOB RESPONSIBILITIES

• Conduct systematic and ad-hoc literature searches in global biomedical databases (e.g., Embase, PubMed, Medline) for ICSR identification and safety-relevant information.
• Skilled in extracting and summarizing key safety information from identified literature sources
• Thorough understanding of creating and validating search strategies for pharmacovigilance purpose.
• In depth knowledge of major literature databases such as Embase, PubMed etc.
• Experience in conducting local literature searches and reviews.
• Understanding of regulatory requirements with respect to global and local literature.
• Enters information into PVG quality and tracking systems for receipt and tracking ICSR.
• May assist in the preparation of the Safety Management Plan
• Processes ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.

o Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.

o Enters data into safety database.

o Codes events, medical history, concomitant medications and tests.

o Compiles complete narrative summaries.

o Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved.

o Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.

o Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases.

• Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports.
• Participate in audits/inspections as required
• 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, GCPs, ICH guidelines, GVP, project/program plans and the drug development process.

Good communication and interpersonal skills, both written and spoken

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.

What we're looking for

• Bachelor's Degree, Postgraduate in health profession with relevant experience, 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.

• At least 3+ years of experience in Pharmacovigilance, Literature case reviewing (Global+Local), Identifying NICR (Signal & AR) report from Literature.

• Mandatory to have GVP Module 6 knowledge
• 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), TeamShare (or other management/shared content/workspace) and internet.
• Ability to work independently and in a team environment
• Good communication and interpersonal skills, both written and spoken
• 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.

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.

Summary

Performs all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR), adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures for clinical trials and/or post-marketing safety programs.