Liaise with business/functional units to influence the design of MAP and GVP SP processes ensuring adequate collection of safety data and their timely reporting to the safety unit.
Perform SP risk assessments to ensure GVP and MAP SPs have Quality Management Systems (QMS) in place.
Responsible for execution of SP Oversight Plan (SPOP).
Acts as single point of contact for all SP communications.
Act as Pharmacovigilance subject matter expert for MAP and GVP SP processes in the event of audit or regulatory inspections.
Identify potential risks and/or gaps associated with GVP and MAP SPs. Develop and execute risk mitigation strategies.
Use appropriate metrics and quality checks to gain sufficient oversight of the MAP and GVP SP processes and its effectiveness, aiming to achieve a desired state of compliance.
Oversee and support implementation of SP CAPAs, as appropriate.
In collaboration with the vendor owner, perform at least annual site visits to GVP and MAP SPs.
Communicates with vendor owner and SP regularly as part of communication plan to drive a desired state of collaboration.
Escalates issues and risks as appropriate to vendor owner, SP PV Oversight Manager and/or SP PV Oversight Head.
Accountable for PV compliance for GVP or MAP SPs.
Competencies Identified for Success:
Ability to adapt in a regularly changing environment
Experienced with engaging key stakeholders
Strong organizational and project management skills
Strong influencing skills and collaborative approach with peers and senior leaders
Excellent communication skills, both written and oral
Works effectively as a team member and promotes collaboration
Appreciation for the importance of Pharmacovigilance compliance in pharma industry
Understanding of Patient Support Programs and Market Research Progams
Education, Experience, and Other Requirements:
Life sciences degree BSc minimum (or >10 years’ experience in a similar role)
3+ years in pharmacovigilance or compliance-related role
8-11 years pharma experience / 6-9 years pharma experience with Masters or RN / 3-6 years with PhD/PharmD
Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations.
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.
At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.