The role is responsible for supporting the Senior Director of Pharmacovigilance (PV) Operations with elements of the pharmacovigilance function. This includes overall accountability for vendor management/oversight; training; business integration; Quality Management System (QMS); Safety Data Exchange Agreements (SDEAs); PV Safety database, and CAPA management.
Responsibilities
Coordinate the daily management and execution of drug safety (DS) and pharmacovigilance (PV) operations.
Work with compliance with regulations, PV agreements, and internal SOPs.
Represent the Drug Safety and Pharmacovigilance departments on clinical development teams.
Oversee SAE (Serious Adverse Event) processing by outsourced vendors, and review and monitor compliance operations.
Execute strategies to achieve and maintain the desired level of quality including, by analyzing and mitigating compliance risk.
Lead Global Patient Safety teams and manage safety strategy for assigned pharmaceutical products.
Responsibilities
Lead Global Patient Safety teams and Safety Management Teams for assigned compounds and products.
Analyse and interpret safety information from clinical, non-clinical, post-marketing and scientific literature sources.
Lead signal detection, evaluation, monitoring, interpretation and ongoing signal management.
Own and communicate the evolving benefit-risk profile of assigned medicines.
Provide medical and scientific interpretation of emerging safety information and ensure significant findings are communicated appropriately to senior stakeholders.
Manages the safety profile of new drugs in clinical trials, oversees case-processing activities through all phases of development, and performs regulatory reporting and medical monitoring tasks.
Responsibilities
Coordinates contracted safety responsibilities for one or more programs, including staffing, training, procedural compliance and technology oversight
Manages the safety team on respective programs
Works with senior management and develops consistent internal processes and ensures compliance with established processes
Proactively liaises with project leads and clients to ensure optimal performance and utilisation of the safety project team and delivery of a high quality service to our clients
Directly fulfils safety scientist activities on assigned projects
Requirements
Bachelor's degree or equivalent and relevant formal academic/vocational qualification
Lead and manage a team of Pharmacovigilance Scientists to oversee safety surveillance, signal detection, risk management, and regulatory compliance for drug safety across the product lifecycle.
Compensation
$185,000.00-252,500.00 Annual
Responsibilities
Allocate resources across products and development programs to ensure timely execution of safety deliverables
Foster a culture of scientific excellence, collaboration, continuous improvement, and regulatory compliance
Provide scientific oversight of routine and ad hoc signal detection activities for investigational and marketed products
Lead the preparation, maintenance, and lifecycle management of core Risk Management Plans (RMPs) and associated safety documents
Ensure consistency between RMPs, Core Safety Information, Investigator's Brochures, and product labeling
Requirements
Master's degree or PhD in Pharmacy, Pharmacology, Life Sciences, Nursing, Public Health, or a related scientific discipline
The Global Medical Safety Lead serves as the company's subject matter expert for medical safety, risk management, and post-market surveillance, responsible for monitoring, evaluating, managing, and communicating the safety profile of products across global markets.
Compensation
Competitive base salary based on experience and qualifications: $158,000-$209,000 (subject to variation depending on physical location).
Responsibilities
Serve as embecta's global medical safety expert and primary resource for medical safety matters.
Provide strategic direction and expert guidance on medical safety matters to senior leadership and cross-functional stakeholders.
Support the development and continuous improvement of Medical Affairs policies, procedures, and governance frameworks.
Drive post-market surveillance activities and trending analyses to identify emerging safety risks.
Support regulatory submissions and responses related to product safety.
Lead the pharmacovigilance group overseeing safety activities for Amneal products from development to post-marketing
Compensation
The salary range for this position ranges from $200,000 - $250,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award as well as a long-term incentive award, such as restricted stock units
Responsibilities
Assess significant safety cases, review cumulative safety data, evaluate signals and benefit-risk, and recommend safety actions.
Lead medical safety oversight for assigned clinical trials and development programs.
Provide medical safety input and review for study documents, safety reports, and regulatory submissions.
Review and approve clinical safety narratives, aggregate analyses, and medical assessments supporting safety reports and regulatory submissions.
Provide medical input into Development Safety Update Reports (DSURs), investigator brochure updates, clinical overviews, integrated safety summaries, and responses to health authority questions.
Expert pharmacovigilance role focused on regulatory compliance, safety management of large projects, risk management strategies, and leading safety initiatives.
Compensation
U.S. Base Salary Range: $137,000.00 - $215,270.00
Responsibilities
Manage large pharmacovigilance projects or processes with limited oversight
Develop and implement risk management strategies for complex situations
Lead the preparation and review of detailed safety reports
Conduct signal detection and safety assessments independently
Engage with stakeholders and regulatory authorities, providing authoritative advice
The Director serves as the first point of contact for all Rare Disease operations including safety data processing, submission creation, and documentation to ensure completeness, accuracy, and timeliness.
Compensation
$205,000.00 - $341,600.00
Responsibilities
Develop, lead, and scale a team comprised of Safety Scientists
Develop common practices, processes and templates to drive standardization and consistency in execution of core activities
Ensure compliance and quality management of Safety Sciences Delivery activities
Lead all aspects of signal detection coordination and signal management process across Rare Disease
Develop innovative approaches to delivering on core activities that integrate in new technologies
Requirements
Advanced Degree in life sciences or healthcare
Nice to have: Oversight of operations within a global patient safety organization
Lead global safety strategy and governance for Obesity and related conditions therapeutic area within Amgen’s global development organization.
Compensation
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible.
Responsibilities
Serve as the accountable physician safety leader for assigned Obesity development programs.
Lead global safety strategy for clinical development programs.
Partner with Clinical Development and Translational Medicine teams to inform dose-escalation, cohort expansion, proof-of-concept, and development decisions.
Provide medical safety leadership and contribute to benefit-risk evaluations throughout clinical development.
Review and interpret emerging safety data and communicate safety implications to development teams and governance committees.
Manager/Sr. Manager, PV Operation - Oncology BiotechNewSystimmune · Princeton, US
Director, Pharmacovigilance & Drug SafetyAmneal · Piscataway, US