Job Purpose: The Senior Safety Scientist is responsible for carrying out pharmacovigilance activities for the assigned product(s). This may include, single case medical review, aggregate reporting, signal detection and evaluation, safety related activities associated with new drug applications / regulatory filings, benefit risk assessment and safety risk management.
The Senior Safety Scientist supports the Safety Science Leader (SSL) and may be responsible for particular aspect(s) of the overall program or a group of products. Applicable tasks are not limited to and may vary by product(s) assigned.
Primary Responsibilities and Accountabilities
Carry out pharmacovigilance and risk management activities for assigned product(s):
Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and tracking and evaluating potential issues
Senior Safety Scientist may support SSL or be responsible for the development and/or the execution of RMP or REMS risk mitigation activities
Prepare and review periodic aggregate 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
Lead/support PDS post-marketing safety study activities
Carry out signal detection activities and evaluation:
Conduct/support signal detection and evaluation according to SOPs and guidelines
Carry out medical review of individual case safety reports (ICSRs), if assigned for the product according to SOPs and guidelines
Prepare safety assessments, drug safety reports, as necessary, for potential signals or issues (product quality)
Respond to safety requests for the assigned product from regulatory agencies or affiliates/ other internal functions
Compliance: Support all relevant compliance activities including implementation of assigned CAPAs
Contribute drug safety input to activities to define and implement the Clinical Development strategy for assigned product(s):
Provide safety content review of clinical protocols, study reports, Investigators Brochure and other related documents to ensure alignment with CDP
Contribute to regulatory authority 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 and provide input for Drug Safety Monitoring Boards or independent monitoring committee meetings, as applicable
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
Whenever assigned by the SSL, the Senior Safety Scientist is responsible for the development and whenever appropriates the execution of RMP or REMS risk mitigation tactics.
The Senior Safety Scientist is differentiated from the Safety Scientist in that the incumbent is consistently willing and able to be successful when employed on the most demanding and complex tasks; has a high degree of independence and autonomy, requiring minimal supervision; is widely respected by other members of the organization for their contribution and competence; acts as a coach, guide, and mentor to peers and direct reports; and makes a contribution to the department beyond the bounds of their routine responsibilities (e.g. in cross-functional teams and working groups).
Who You Are
Professional and Technical Requirements:
Strong knowledge of international drug regulation including GCP, GVP and GMP
Minimum: PhD, PharmD, Pharm, MS, MPH or equivalent BioScience qualification
Desired: MD is preferred
Experience, Skills, Knowledge:
Prior industry experience in drug safety, clinical development or medical affairs (at least 2 years)
For MD candidates - clinical practice experience (at least 3 years preferred, may include residency)
Good knowledge of pharmacovigilance practices and tools (e.g. databases, signal detection tools, MedDRA)
Good knowledge of US and EU pharmacovigilance regulatory requirements
Good medical and scientific judgment
Ability to evaluate, interpret and present scientific data with clarity 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
Travel Requirements: Able to undertake international travel as necessary
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.