Lead patient safety activities within your assigned US Medical Affairs Medical Network with considerable autonomy. Serve as the primary point of contact for assigned USMA Medical Team(s) and Roche Safety Strategy Leaders. Collaborate in ongoing signal management activities with Clinical Safety Teams/ Roche Safety Strategy Leaders. Act as an expert on Health Authority Regulations and support US PS management with interpretation. Ensure compliance with health authority regulations and guidance doc... more details
Join our team as a highly skilled and experienced Senior Pharmacovigilance Clinical Product Scientist. In this role, you will play a vital role in ensuring the timely completion of US Patient Safety activities for assigned US Medical Affairs Medical Network(s) and products. As a Senior PV Clinical Product Scientist, you will serve as an internal and external spokesperson on cross-functional teams, demonstrating expert knowledge of protocol management in accordance with PV standards. Your scientific, strategic, and operational responsibilities will support our US Patient Safety goals and objectives.
The Opportunity:
Lead patient safety activities within your assigned US Medical Affairs Medical Network with considerable autonomy.
Serve as the primary point of contact for assigned USMA Medical Team(s) and Roche Safety Strategy Leaders.
Collaborate in ongoing signal management activities with Clinical Safety Teams/Roche Safety Strategy Leaders.
Act as an expert on Health Authority Regulations and support US PS management with interpretation.
Ensure compliance with health authority regulations and guidance documents for ICSR submissions.
Oversee and implement internal manuals, safety SOPs/Work Instructions, and external collaboration agreements.
Mentor and support less experienced PV Clinical Product Scientists.
Who You Are:
Health Care Professional Bachelor's degree with strong academic background (RN/BSN/MSN, PA, NP, RPh/PharmD/B.Pharm, or MD/MBBS) with 5+ years of pharmaceutical/biotechnology relevant industry experience with minimum 2 years of pharmaceutical/biotechnology relevant experience.
Strong clinical acumen and advanced knowledge of PV-related regulations.
Works effectively both independently and collaboratively.
Strong organizational skills and detail-oriented in a fast-paced, changing environment.
Demonstrates ownership, initiative, accountability, and the ability to manage change.
Customer-oriented with the ability to thrive in an agile environment.
Analytical and problem-solving capabilities, with the ability to make decisions of moderate complexity.
Excellent communication and presentation skills.
Ability to manage multiple priorities effectively and efficiently.
Good interpersonal and influencing skills, with the ability to establish rapport and influence without authority.
Strong attention to detail.
Computer skills and database experience (Microsoft Office Suite or Google).
Experience in data analysis, interpretation, and medical writing.
Understanding of and/or previous experience with Phase I - III and/or Phase IV drug development.
Preferred:
Proven record in developing strong relationships with external constituents (therapeutic area experts, external organizations, etc.).
Proven track record of meeting or exceeding objectives and goals.
Project Management
Prior experience leading a team and/or managing people.
Ability to travel 10% per business needs
This may be a remote based role.
The expected salary range for this position based on the primary location of South San Francisco, California is $143,300 to 269,900. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
Benefits
Relocation benefits are not available for this job posting.
Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.
