Job Number: 20-10258
Job Number: 20-10258
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Physician for our client in Lawrence Township, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- Oversee, Prepare, and/or Review aggregate safety review documents (e.g., DSUR, PBRER) and safety sections of relevant clinical trial documents (e.g., protocols, clinical study report [CSR], investigator brochure [IB], informed consent form [ICF]) and regulatory filings (e.g., clinical trial applications [CTA], marketing authorization applications [MAA]).
- Provide safety input to clinical development plans, study protocols, amendments, IB, statistical analysis plan (SAP), ICF, CSR, responses to HA or institutional review board (IRB)/ ethics committee (EC) queries.
- Lead the evaluation & management of signals emerging from any data source.
- Develop strategy for signal evaluation (e.g., case-series, literature review, HA/ claims database). Document by Safety Topic Review/ Signal Report or other means of communication.
- Lead safety activities and benefit-risk strategies for assigned Client compound(s)/ program and chair the product SMT(s) as required.
- Assist the team and senior management in all forms of issue management and crisis management
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
John Bayog | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.