PVC Product Manager

4 weeks ago

Los Angeles, California, United States Genentech Full time
The Position

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.

This role can be fully remote.

The Opportunity:

Join our team as a Pharmacovigilance Clinical Product Scientist Manager and make a significant impact in the safety and success of our clinical research and product launches. You will lead and manage PV medical/clinical activities, provide safety oversight for USMA clinical research, and ensure effective communication of safety-related content. Key responsibilities include identifying concerning adverse event reports, supporting US product launches, overseeing FDA ICSR submissions, and collaborating with Clinical Safety and medical teams. Additionally, you will establish a network of experts, influence key stakeholders, and coach and develop your team in a dynamic, inclusive environment.

Responsibilities:
  • Develop and facilitate working relationships with US Medical Partners and Medical Networks across USMA portfolio, sometimes in conjunction with US Patient Safety Strategy Partner and PV Clinical Product Science Therapeutic Area leads.
  • Manage subject matter expertise for all types of case processing, including IND submissions, and provide guidance and oversight of quality within the PV Clinical Team.
  • Lead or play a key role in various health authority inspections, including those by FDA, MHRA, EMA, BfArM, and license partner audits.
  • Conduct preliminary impact assessments of new and/or revised global business processes based on PV regulatory requirements and propose solutions as needed.
  • Lead the creation and implementation of organizational strategies, goals, and objectives for the department, including new safety initiatives and Health Authority safety requirements.
  • Collaborate with key stakeholders to provide expertise and guidance for interdepartmental and cross-functional team activities, including process improvement standards and metrics.
  • Maintain positive relationships with Global Pharmacovigilance Patient Safety and other Affiliates to address safety queries, share best practices, and discuss new safety regulations.
Who You Are:

Required:
  • Bachelor's degree with strong academic background (RN/BSN/MSN, PA, NP, RPh/PharmD/B.Pharm, or MD/MBBS) with 6+ years of pharmaceutical/biotechnology relevant industry experience with expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations.
  • Minimum of 2 years in a supervisory role, with strong clinical competence and advanced knowledge of PV-related regulations, including Phase I-IV drug development.
  • Demonstrates ownership, initiative, accountability, and the ability to manage change, with strong organizational skills, attention to detail, and the ability to manage multiple priorities in a fast-paced, changing environment.
  • Excellent communication and presentation skills, with good interpersonal and influencing abilities to establish rapport and influence without authority.
  • Strong analytical and problem-solving capabilities, with experience in data analysis, interpretation, and medical writing, capable of making decisions of moderate complexity.
Preferred:
  • Knowledge of EMEA regulations preferred
  • 2+ years of leadership experience in a comparable pharmacovigilance organization.
  • 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.
Travel Requirements:

Ability to travel 10% per business needs

The expected salary range for this position based on the primary location of South San Francisco, California is $149,000 to 276,000. 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.

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