Makro Scientific:

Growing Pharmaceutical, Biotechnology and Medical Device companies always need TOP Talent. Since 1996, MakroScientific’s proven staffing solutions have helped many Life Sciences companies succeed and visualize their goals by increasing innovation and decreasing costs while maintaining the complex service level expectations.

Our global presence with offices in USA (NJ, PA, IL, CA) and offices in UK, Europe and Asia enables us to be a powerful contributor and connector of right Talent.

Job Order ID : 43017
Location : South San Francisco, CA
Duration : 8+ Months
Job Title : Scientist I

Job Description:

• Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and highlighting and tracking potential issues
• Prepare and review periodic safety reports (PBRER / PSUR, DSUR, EU renewal and other Annual Safety Reports) in accordance with regulatory requirements and standard operating procedures
• Support the preparation and maintenance of safety sections of the Company Core Data Sheet
• Conduct/support signal detection and evaluation according to SOPs and guidelines
• Provide safety content review of clinical protocols, study reports, Investigators Brochure and other related documents to ensure alignment with CDP
• Contribute to regulatory agency submissions (IND applications, NDAs, MAA’s, Variations, Renewals) by reviewing safety data and preparing relevant sections of the filing documents and submission packages
• Participate in or provide input for Drug Safety Monitoring Boards or independent monitoring committee meetings, as applicable
• The Safety Scientist should develop a clear understanding of the safety issues and a thorough knowledge of the from the drug mode of action, to enable support the SSL
• The timely medically and scientifically sound development of the clinical safety portions of a product development plan (PDP) and develop an understanding of the safety profile of the assigned product

Skills:

• Strong knowledge of international drug regulation including GCP, GVP and GMP
• Prior industry experience in drug safety, clinical development or medical affairs is desirable
• MD candidates - clinical practice experience (at least 3 years preferred, may include residency)
• Good knowledge of pharmacovigilance practices
• Good knowledge of US and EU pharmacovigilance regulatory requirements

Education:

• MS or MD, PhD or PharmD Preferred, or equivalent qualification.