Sr SPVG Scientific Spec – Literature Review + QC
Full time @Syneos Health Clinical posted 8 months ago in Pharma Shortlist Email JobJob Detail
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Job ID 8829
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Career Level Executive
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Experience 2 Years
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Gender MaleFemale
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Category / Function Management
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Qualifications Degree Bachelor
Job Description
Description
Senior SPVG Scientific Specialist
Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
Why Syneos Health
- #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
- We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health – physical, mental and financial.
- 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
- Collaborates with the Client and internal project management associates for safety and pharmacovigilance activities including (but not limited to) literature screening and review, drug coding, maintenance of drug dictionary, Medical Dictionary for Regulatory Activities (MedDRA) coding, case processing or review of individual case safety reports, authoring or review of aggregate reports and ongoing safety evaluation activities. The processing of information may include filtering, cleaning, migrating, analysing, reporting, filing or publication of data and information.
- Participates in project launch activities for safety and pharmacovigilance programs
- Maintains safety tracking for assigned activities
- Provides support and advice on safety and pharmacovigilance program issues to project team/Sponsor as required
- Fosters constructive and professional working relationships with all project team members, internal and external
- Assists in the preparation of data for internal project review meetings and participates as required
- May be responsible for distributing and monitoring team workload
- Participates in audits as required/appropriate
- Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities
- Files documents according to project specific requirements (electronically or in hard copy as applicable)
- Provides support with miscellaneous project tasks related to safety and pharmacovigilance activities
- Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Program Specific FIle or Pharmacovigilance System Master File for post-marketing programs as appropriate
- Assists in the tracking and measuring of program/project and team progress through collection of cycle time metrics and other key performance indicators (KPIs).
- Participates in audits as required/appropriate
- Provides support with miscellaneous project tasks related to safety and pharmacovigilance activities
- Maintains an understanding and compliance with Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, the drug development process and GVP