Sr Safety Physician – Aggregate Reports
Full time @Syneos Health Clinical posted 8 months ago in Pharma Shortlist Email JobJob Detail
-
Job ID 9083
-
Career Level Executive
-
Experience 2 Years
-
Gender MaleFemale
-
Category / Function Management
-
Qualifications Degree Bachelor
Job Description
Description
Senior Safety Physician
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
- Performs medical review of adverse events reported for both investigational and marketed products
- Maintains familiarity with MedDRA, WHO-DRL and safety databases such as ARGUS.
- Works closely with Safety and Pharmacovigilance (SPVG) colleagues to ensure appropriate medical interpretation and consistency are applied to adverse event case assessment
- Ensures regulatory and SOP compliance with respect to evaluation, reporting and surveillance of clinical and post-marketing safety information
- Identifies, communicates and effectively manages potential safety issues
- Interacts with client’s safety/medical personnel as appropriate
- Stays abreast of clinical and drug development information relevant to contracted programs
- Provides medical review and interpretation for aggregate safety reports (e.g. annual safety reports, PSURs, PADERs)
- Participates in medical safety surveillance/signal detection benefit/risk assessment, and development of trend analyses
- Participates in the development of REMS and RMP as required
- Maintains medical and pharmacovigilance expertise through appropriate internal or external continued medical education (CME)
- Serves as a mentor for other internal safety staff including case processing staff
- Supports business development activities as required
- Responsible for performing activities that are in compliance with applicable Corporate Policies, Standard Operating Procedures, Work Instructions and project specific Operating Guidelines
- Performing other duties as assigned by management.
Qualifications
What we’re looking for
- The incumbent should possess M.D.,MBBS, D.O.
- Should have 2+ years of relevant expereince in Aggregate Report (PSUR, DSUR, PABER, PADER,Clinical/Integrated Summaries)
- Should have 2+ years of relevant expereince Pharmacovigilance department