Principal Safety & PV Specialist (Literature CP & Review)

Principal Safety & PV Specialist (Literature CP & Review)

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
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 deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

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.
  •    Coordinating workflow to ensure delivery of project.
  •    Prepares Safety Management Plan  

• •    Responsible for work allocation, compilation and reporting of the program reports on timely basis

• •    Create error-free reports and other outputs according to the defined specifications to ensure timely reporting of assigned job to program management 
  •    Support identification and provides standards for gathering information for use in trend analysis
  •    Identifies and provides standards for gathering information for use in trend analysis and reports information to company management
  •    Responsible for process implementation and ensuring process compliance 
  •    Responsible for managing program deliverables in line with the program management plan 
  •    Assists in the preparation and participates in internal project review meetings as required.
  •    May enter information into PVG quality and tracking systems for receipt and tracking ICSR.
  •    May process 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.
  •    Provides training of Investigators on ICSR reporting
  •    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.
  •    Reviews and provides solutions for issues relating to program delivery or escalates appropriately to the Program Lead / Program Director as required
  •    Support identification and provides standards for gathering information for use in trend analysis 
  •    Act as a subject matter expert and help the team members with day-to-day trouble shooting activities 

What we’re looking for

•   Educational Qualification: B.Pharm/M.Pharm/PharmD/BDS/BMS

•   Minimum 8 Years of experience in Literature Case processing is required along with team lead experience.

•   Location: Gurugram/Hyderabad Office based role
•    Safety Database systems and knowledge of medical terminology required
•    In depth 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
•    Strong communication, presentation, interpersonal skills, both written and spoken
•    Strong 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
•    Able to make effective decisions
•    Minimal travel may be required (up to 10%)

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.