Job Number: 21-07872
Job Number: 21-07872
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Pharmacovigilance Scientist for our client in Summit, 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!
- Lead Safety Data Review (SDR) Teams and participate in related PV and product-development subteam(s). Appropriately elevate signal detection findings impacting key MST activities, milestones, and documents to the MST Chair
- Support individuals in aspects of project management, drug development and MST requirements, as appropriate to meet overall MST/subteam needs
- Author and contribute to specified PV sections of the PBRERs and DSURs with oversight, as needed
- Author responses to safety data queries from health authorities including coordination and integration of scientific, medical, and regulatory input from a variety of scientific sources and functional groups, as needed to support responses to safety data/ad hoc queries and HA requests
- Perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data
- Collaborate within and across Client functions with appropriate disciplines to identify and ensure management of internal and external documentation and support when required
- Apply knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities. Share with individuals and teams on these applied learnings
- Minimum of 8-10+ years BS/RN; 7 -10 years MS/PharmD/PhD/MD or equivalent relevant Pharmaceutical Industry experience
- Strong understanding of medical concepts, drug development, pharmacovigilance, risk management and global regulatory safety and risk management health authority requirements and submission milestones
- Strong understanding of project planning methods; demonstrated ability to manage timelines and to prioritize; ability to align operational milestones and activities with operational representatives in other functional areas
- Appropriately escalates issues that could impact activity timelines or quality
- Ability to effectively lead and work well within cross-functional teams, using strong organizational, facilitation, and interpersonal communication skills
- Strong understanding and communication of scientific subject matter, including authoring scientific documents (eg, pharmaceutical regulatory documentation and/or publications in peer-reviewed journals).
- Attention to detail along with excellent scientific, analytical and conceptual skills
- Demonstrated ability to understand, research, independently investigate, interpret, and reach reasoned conclusions regarding complex medical-scientific data from a broad range of disciplines (eg, clinical trial laboratory data, nonclinical data, postmarketing reports, scientific literature, and regulatory documents)
- Demonstrated excellent knowledge and use of MS Office (or other equivalent Client office suite) programs such as Excel and PowerPoint; applying technical skills to analyze and summarize scientific-medical-safety data, and to portray and summarize scientific-medical-safety concepts and teach these capabilities to others
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.