Safety Scientist (Contract)

Mirati is looking for a Safety Scientist to join our growing team. This position is responsible for global safety assessment of investigational and marketed products throughout their lifecycle. This includes all pre- and post-marketing safety, Pharmacovigilance (PV) and supporting signal detection and risk management activities. This individual will manage the safety assessment of products, including medical review of individual and aggregate S/AEs and the scientific literature, and preparing safety reports including DSURs/PSURs. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.

RESPONSIBILITIES

• Contribute to the identification, analysis and reporting of possible safety trends and concerns with Mirati products, including the identification and evaluation of safety signals through the assessment of individual case safety reports and aggregate data summaries from clinical studies and post marketing experience, review of relevant literature articles, product quality complaints and non-clinical safety data
• Research and carry out signal detection activities utilizing internal and external sources of investigational or marketed product safety data
• Contribute to developing, implementing and coordinating risk mitigation strategies (e.g. Risk Management Plans, REMS, Post-Marketing Evaluation Programs), to ensure the safe and appropriate use of Mirati products, in compliance with global legal and regulatory requirements
• Coordinate and contribute to the production of all relevant regulatory documentation (e.g. IND Annual Reports, DSUR, PSUR) as well as clinical documentation (e.g. Protocols, IBs, ICFs)
• Support and collaborate with business partners around safety data evaluation and safety data exchange, including the creation of safety data exchange agreements, review of safety materials received from our partners
• Contribute and provide support required to respond to medical inquiries regarding safety issues, ad hoc requests from regulatory agencies, etc., as needed
• Support AE/SAE reconciliation when questions arise requiring clinical understanding
• Represent PV and Safety Risk Management Department as applicable
• Under the direction/review of senior PV staff, participate in other PV and Safety Risk Management activities as necessary

REQUIREMENTS

• Worked with a drug safety database (ARGUS experience helpful) and have had responsibility for medical review of SAE reports
• Thorough knowledge of current US, Global, and ICH safety reporting regulations and guidelines
• MedDRA trained and working knowledge of MedDRA and WHODrug coding dictionaries
• Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork
• Competent in Microsoft Word, PowerPoint, Excel
• Ability to maintain an “inspection ready” environment
• Ability to work independently
• Strong attention to detail

EDUCATION & EXPERIENCE

• Minimum of a PharmD, MD, DO, or NP with at least 5 years' experience in Drug Safety and PV
• Solid medical knowledge of methods to assess causality relationship between adverse events and administration of Company products
• Clinical development and post marketing experience highly desired
• Relevant experience in the oncology therapeutic area, strongly preferred

EOE