- Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
- The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
- The Safety Scientist is responsible for or supports various pharmacovigilance and risk management/minimization activities for company’s investigational and marketed products
- Author and coordinate/project manage development of periodic safety reports (e.g., PSUR/PBRER, PADER, DSUR, etc) in accordance with company SOPs and regulatory requirements
- Support preparation and maintenance of Risk Management plans
- Contribute to development of signal detection strategy for post marketed products
- Support signal detection, evaluation and management according to the company SOPs and guidelines
- Support development and/or maintenance of core and local label for company products (e.g., CDS, USPI, SmPC, IB, etc)
- Serve as the Safety Lead for one more company clinical programs
- Assist in oversight of Pv vendors/CROs as applicable
- Contribute to preparing safety assessments reports
- Participate in preparing responses to safety related requests from health authorities
- Provide safety content review of clinical protocols, CSRs, and ICFs
Experience, Skills, Knowledge:
- Ability to critically analyze individual and aggregate safety data with scientific rigor
- Previous experience in preparing periodic safety reports and risk management plans
- Strong relationship building skills, with ability to interact effectively in a multifunctional and multicultural team setting
- Excellent written and verbal communication skills to a variety of levels and teams, internally and externally.
- Demonstrated persuasion, influencing and negotiation skills
- Ability to operate objectively and independently as a leader and as a member of a team, as required
- Effective team player, with proven ability to effectively lead projects and teams to successful conclusion.
- Bachelor's level degree in life sciences required; MD, PharmD or PhD highly preferred.
- At least 5 years of direct Pharmacovigilance Safety Science is required.
- Solid knowledge of FDA, EMA, and ICH safety reporting regulations and GVP guidelines.
- Strong knowledge of safety database (preferably ARGUS), MedDRA, and WHO Drug
- Strong quality focus, with a good understanding of quality systems.
- Excellent communicator, both oral and written, specifically medical writing skills
- Our company is an equal opportunity employer.
- We are able to offer the opportunity to be part this successful, fast growing company. A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.