Job Function: Development
Job Level: Experienced
Who We Are
At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.
The Position The Safety Scientist is responsible for carrying out pharmacovigilance activities on a product or group of products, including single case processing, aggregate reporting, signal detection and evaluation of PV database.
The Safety Scientist supports the Safety Science Leader and is responsible for a particular aspect(s) or segments of the overall programme. The job-holder contributes to the benefit risk evaluation and to safety risk management.
Primary Responsibilities and Accountabilities:
Carry out pharmacovigilance and risk management activities for specific product or products:
- Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and highlighting and tracking potential issues
- Support the preparation and maintenance of Risk Management plans for the submission to Regulatory Authorities
- Prepare and review periodic safety reports (PSUR, EU 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
- Lead/support PDS post-marketing safety study activities
- Coordinate safety activities between PDS and internal and external partners
Carry out signal detection activities and evaluation:
- Conduct/support signal detection and evaluation according to SOPs and guidelines
- Carry out medical review of spontaneous case reports and Serious Adverse Event reports from clinical trials, according to SOPs and guidelines
- Prepare Drug Safety reports, as necessary, for potential signals
- Respond to queries relevant to the safety of Roche products from the affiliates and other internal functions
Contribute drug safety input to activities to define and implement the Clinical Development strategy for a product or group of products:
- Provide review of clinical protocols and study reports to ensure alignment with CDP and safety adequately addressed, and contributes to the safety section of the Investigators Brochure (IB)
- Contribute to regulatory authority submissions (NDAs, MAA's, Variations) by reviewing safety data and preparing relevant sections of the submission
- Participate in or provide input for Drug Safety Monitoring Boards, as necessary
- Provide support to the SSL
- In the case of early projects support the SSL by developing a clear understanding of the safety issues from the drug mechanism
- The timely medically and scientifically sound development of the clinical safety portions of a product development plan (PDP).
- Whenever assigned by the SSL, is responsible for the development and whenever appropriate the execution of RMP or REMS risk mitigation tactics.
Who You Are Minimum:
- PhD, PharmD, Pharm, MS or equivalent qualification and good medical competence in the relevant therapeutic area may be considered
- Desired: MD is required
- Good knowledge of pharmacovigilance practices
- Good knowledge of US and EU pharmacovigilance regulatory requirements
- Excellent written and verbal communication skills and ability to present and critically discuss clinical data in both internal and external discussions
- Ability to evaluate, interpret and synthesize scientific data (analytical thinking)
- Team player with ability to function in a multi-disciplinary environment
- Self -motivated, able to prioritize and plan effectively
- Attention to detail
- Fluent in English (verbal and written)
- Good negotiating and influencing skills
- Good computing/IT skills
Deadline: Contact employer