Safety & PV Specialist – Immediate Joiner Only
Job type; Remote
Description – External
Safety & Pharmacovigilance Specialist
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 unites us globally, and we are dedicated to caring for 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 a diversity of thoughts, backgrounds, cultures, and perspectives – we can create a place where everyone feels like they belong.
Job Responsibilities
- Enter information into PVG quality and tracking systems for receipt and tracking ICSR.
- Assists in processing ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
- Triages ICSRs evaluate ICSR data for completeness, accuracy, and regulatory report ability.
- Enters data into the 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 queries are satisfactorily resolved.
- Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
- 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.
Qualifications –
What we’re looking for
- 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.
- Must have 2+ Years of experience in ICSR Case Processing
- Must have working experience on Argus
- Should be Immediate Joiner
SUMMARY; Syneos Health is looking for a Safety & Pharmacovigilance Specialist with at least 2 years of experience in ICSR case processing and working experience on Argus. The candidate should have a Bachelor’s degree in life science, be a registered nurse, pharmacist, or an equivalent combination of education and experience. The role involves entering information into PVG quality and tracking systems, processing ICSRs according to SOPs and safety plans, evaluating ICSR data, and generating timely and accurate reporting of expedited reports. The candidate must be an immediate joiner and know global drug/biologic/device regulations, GCPs, ICH guidelines, and GVP.
