Sr. Pharmacovigilance (PV) Clinical Scientist

Job Description

Job Description

Job Title: Sr. Pharmacovigilance (PV) Clinical Scientist Job Description

The Sr. Pharmacovigilance (PV) Clinical Scientist within the US Patient Safety PV Compliance Team plays a critical role in the clinical review, evaluation, and processing of adverse event information. This position leads the clinical review of cases processed in-house and by external vendors, ensures high-quality Individual Case Safety Reports and Health Authority submissions, and supports PV leadership in maintaining compliance with global pharmacovigilance regulations and internal standard operating procedures. The role requires deep expertise in case processing, strong leadership and project management skills, and the ability to work autonomously while collaborating effectively with cross-functional partners.

• Perform timely, thorough, and accurate drug safety monitoring and tracking in accordance with pharmacovigilance standards, regulations, and internal standard operating procedures.
• Review, evaluate, and verify potential adverse event information during triage to determine required actions and complete data entry of adverse events in the global safety database.
• Conduct medical assessment of cases, including seriousness, validity, and causality, and perform quality review of all cases as applicable.
• Perform labeling assessments for adverse events using clinical knowledge and conduct follow-up for all reported cases as appropriate.
• Lead efforts to ensure the quality of Individual Case Safety Reports is aligned with company standards and regulatory expectations.
• Maintain thorough knowledge of Individual Case Safety Report requirements for assigned therapeutic areas.
• Perform trend analysis of vendor case processing issues for assigned therapeutic areas and escalate concerns to vendor leads and US Patient Safety management as needed.
• Update and create standard operating procedures and lead process improvement initiatives to enhance case processing and compliance.
• Develop executive summaries on quality trends observed on a quarterly basis and present key findings to stakeholders.
• Ensure the quality of Health Authority submissions meets local regulatory requirements.
• Lead clinical review of cases processed in-house and by vendors to ensure accuracy, completeness, and compliance.
• Analyze case processing data to evaluate error rates and identify potential compliance impacts, recommending corrective actions where necessary.
• Train internal US Patient Safety staff and vendor teams on pharmacovigilance processes and ensure ongoing PV compliance.
• Collaborate with internal departments and external partners on drug safety data exchange to support seamless and compliant information flow.
• Ensure appropriate data correction in the safety database for identified issues or errors and monitor the effectiveness of corrective actions.
• Maintain and update follow-up templates and ensure successful transmission of all follow-up attempts via the correspondence module.
• Train internal and external staff on using the correspondence module and perform reconciliation of outgoing communications.
• Maintain robust knowledge of Technical Product Complaints and Medical Product Complaints for all company products, including combination products.
• Ensure all product complaints are reported to appropriate stakeholders within defined timelines.
• Perform due diligence to obtain missing or additional information for adverse events in accordance with company procedures and local and global regulations.
• Escalate issues related to follow-up activities and provide strategic resolutions to US Patient Safety management.
• Assist US Patient Safety management in maintaining oversight of Good Pharmacovigilance Practice vendors.
• Identify risks and gaps related to case processing for GVP vendors and propose mitigation strategies.
• Continuously monitor feedback from stakeholders and vendors to inform quality improvements and process updates.
• Perform impact assessments for new or updated company standard operating procedures or Health Authority requirements related to Individual Case Safety Report processing and implement required process changes.
• Identify and develop training documents, including standard operating procedures and guidance materials, for targeted audiences as needed.
• Assist in adverse event reconciliation activities and Case Transmission Verification as applicable.
• Act as a single point of contact with key stakeholders for safety-related activities, identify potential business gaps, and assist in the development and implementation of process solutions.
• Lead assigned projects under the direction of US Patient Safety PV Clinical management, ensuring delivery on time and in line with quality expectations.
• Prepare and develop Patient Safety presentations and participate in internal and external education for stakeholders and vendors.
• Serve as a Subject Matter Expert for safety-related activities within the global safety database and ensure adherence to relevant standard operating procedures.
• Provide support during audits and inspections, including preparation of documentation and responses to findings.
• Collaborate with other patient safety teams as needed to ensure alignment and consistency in safety processes and practices.

• Health care professional degree such as RN, BSN, MSN, NP, RPh, B Pharm, Pharm D, or MD.
• Minimum 5 to 7 years of experience in a biopharmaceutical company with pharmacovigilance responsibilities, or equivalent clinical experience.
• Thorough understanding of FDA safety regulations, ICH guidelines, EMA regulations, and the global pharmacovigilance regulatory environment.
• Demonstrated ability to comprehend and interpret complex medical information.
• Strong ownership, initiative, and accountability in managing pharmacovigilance activities.
• Sound decision-making abilities, including systematic gathering of information, assessment of issue complexity, and effective prioritization of tasks.
• Dynamic leadership skills with the ability to guide projects and coach colleagues with less experience.
• Ability to work independently with minimal supervision and to collaborate effectively within cross-functional teams and with external partners.
• Ability to exercise independent judgment and discretion in matters of significance related to patient safety and compliance.
• Capability to work on complex issues requiring in-depth evaluation of variable factors and data.
• Highly effective communication and presentation skills, with the ability to summarize and present key considerations and decision points to diverse audiences.
• Strong attention to detail in reviewing cases, establishing priorities, and meeting deadlines.
• Proven project management skills to plan, execute, and monitor pharmacovigilance and compliance initiatives.
• Science or medical writing experience, including preparation of summaries, presentations, and training materials.
• Computer proficiency and accurate data entry skills for working within global safety databases and related systems.
• Ability to travel domestically and internationally based on business needs.

• Experience working in a biopharmaceutical environment with direct pharmacovigilance responsibilities is preferred.
• Experience with global safety databases and related pharmacovigilance systems.
• Familiarity with Good Pharmacovigilance Practice vendor oversight and quality management.
• Experience developing and updating standard operating procedures and process documentation.
• Experience leading process improvement initiatives and implementing changes based on regulatory or procedural updates.
• Experience conducting trend analyses and preparing executive summaries on quality and compliance metrics.
• Experience supporting audits and inspections in a regulated environment.
• Ability to thrive in an agile, fast-changing environment and adapt quickly to new requirements.
• Strong collaboration skills for working with internal teams, vendors, and external partners.
• Experience in training internal and external stakeholders on pharmacovigilance processes, systems, and correspondence modules.

This role follows a hybrid working model based in South San Francisco, California, combining on-site collaboration with remote work. The standard schedule is Monday through Friday, from 8:00 AM to 4:30 PM Pacific Time. The position operates within a highly regulated, data-driven patient safety environment that relies on global safety databases, standardized correspondence modules, and structured documentation practices. Work involves close collaboration with cross-functional teams, external vendors, and global partners, with a focus on accuracy, compliance, and timely execution of safety-related activities. Occasional domestic and international travel may be required to support business needs, training, audits, or cross-functional initiatives. The environment emphasizes professionalism, attention to detail, and adherence to internal standard operating procedures and external regulatory requirements.

This is a Contract position based out of South San Francisco, CA.

The pay range for this position is $39.00 - $61.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a hybrid position in South San Francisco,CA.

This position is anticipated to close on Jul 31, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

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