Senior Pharmacovigilance Specialist

Senior Pharmacovigilance Specialist

About this Role

Key Accountabilities:

General

• Maintain expert-level knowledge of safety profiles, labeling, and global regulations
• Lead development of project-specific procedures and workflows
• Provide technical guidance to junior team members
• Prepare for and participate in audits and inspections
• Analyze metrics and drive continuous improvement
• Collaborate with cross-functional teams on safety deliverables
• Identify risks and recommend mitigation strategies
• Ensure compliant documentation and archiving

ICSR Processing

• Lead project management including safety procedure development and database setup
• Coordinate ICSR processing workflows and perform case assessment (seriousness, causality, expectedness)
• Manage case documentation including narratives, reconciliation, and quality control
• Generate safety reports, listings, and respond to ad hoc requests
• Support quality assurance activities, audits, and file maintenance
• Collaborate with Medical Directors and represent team in client/investigator meetings
• Delegate tasks appropriately and escalate scope changes to management
• Assist with resource planning and cross-functional coordination
• Generate, report, and reconcile compliance metrics in coordination with internal and external stakeholders, as applicable

Safety Submissions

• Execute ICSR and periodic report submissions to authorities with expert-level proficiency
• Manage portal/gateway setup and product registration processes
• Coordinate unblinding procedures and aggregate report schedules
• Quality control case reports and listings
• Develop and refine global safety reporting procedures and systems
• Analyze compliance metrics and lead quality improvement initiatives
• Serve as SME in regulatory reporting requirements and represent team in audits
• Mentor junior staff and contribute to strategic project management
• Lead client meetings and support cross-functional coordination for timely submissions

Literature (Search and Review)

• Develop and maintain comprehensive literature search strategies aligned with client parameters
• Process citations, review records, and maintain local journal monitoring
• Perform quality checks on search methodologies and implement thesauri updates
• Screen publications for adverse drug reactions and potential safety signals
• Flag relevant findings for medical review and signal detection
• Resolve literature search issues through stakeholder collaboration
• Stay current with literature review guidelines and support training initiatives
• Monitor literature review activities to be aligned with global pharmacovigilance regulations (e.g., EMA, FDA, ICH) and client-specific requirements.

Affiliate Services

• Serve as primary liaison between global safety operations and local affiliates
• Maintain product information and reporting rules in client systems
• Coordinate safety information exchange between headquarters and country offices
• Ensure local compliance with country-specific pharmacovigilance requirements; Support compliance activities including late case investigations
• Support local health authority interactions and information requests
• Manage translation requirements for safety documents across regions
• Coordinate local literature monitoring programs with affiliate teams
• Support implementation of global safety processes at local level
• Provide training to affiliate staff on pharmacovigilance procedures
• Manage follow-ups and query resolution
• Perform periodic data reconciliation and manage safety communications
• Participate in regular client meetings

Regulatory Intelligence

• Research and maintain drug/device safety reporting regulatory intelligence
• Conduct country requirement reviews and support QC activities
• Liaise with authorities to obtain regulatory updates
• Maintain databases and respond to safety reporting queries
• Support GPIO team operations and client interactions
• Ensure compliance with SLAs and KPIs for internal/external clients
• Provide functional expertise to PV Operations staff
• Support audits and process improvement initiatives
• Serve as SME for stakeholders and mentor new team members
• Stay current with relevant regulations and procedures
• Disseminate timely and actionable intelligence to internal teams and clients through summaries, alerts, and presentations.
• Work closely with cross-functional teams including Regulatory Affairs, Quality Assurance, and Safety Operations to ensure alignment and integration of regulatory changes.
• Maintain a centralized repository of regulatory intelligence and contribute to the development of SOPs, training materials, and best practices.

Regulatory Support

• Manage regulatory applications, submissions, and product lifecycle changes in Safety databases
• Assess regulatory impact for variations and create marketing packages
• Support global regulatory activities across multiple regions (EU, US, Asia, Middle East, Africa)
• Perform data remediation for product portfolios during mergers/acquisitions
• Prepare submission packages and track regulatory documents (RMP, PBRER, HASR, PASS)
• Validate data against SmPC and manage xEVMPD submissions
• Create quality control reports and provide technology support
• Maintain accurate records and perform reconciliation activities

Skills

• Expert knowledge of drug safety regulations and pharmacovigilance processes
• Strong analytical and problem-solving abilities
• Excellent communication and presentation skills
• Superior organizational and time management capabilities
• Proficiency with pharmacovigilance systems and databases

Knowledge and Experience:

• Proven experience in safety case management and regulatory reporting
• Proficiency with safety databases and data analysis
• Strong knowledge of ICH guidelines and regional requirements
• Demonstrated mentoring abilities and process improvement skills
• Experience in pharmaceutical or healthcare environments

Education

• Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience

• Cell and Gene

• Our Cell and Gene Therapy Center of Excellence (COE) integrates regulatory expertise with a cross-functional team to get treatments to market faster.

• Learn more

• General Medicine

• Our general medicine thought leaders provide innovative development strategies and principled trial design and conduct across the following indications: Cardiovascular, Endocrinology and metabolism, Nephrology and genito-urinary, Respiratory, and Women’s health.

• Learn more

• Hematology

• Our specialists in hematology have long been at the cutting edge of innovations, treating patients participating in clinical trials from first-in-human to post-market studies across the indications of Lymphoma, AML, MDS, multiple myeloma, Benign and malignant disorders.

• Learn more

• Infectious Disease and Vaccines

• Our infectious disease team is built upon the global experience and public health knowledge that drives research within these indications: Hepatitis B, Bacterial indications, Vaccines, preventative, and treatment, Critical care, Long COVID syndrome.

• Learn more

• Inflammation and Immunology

• Our broad knowledge of the underlying mechanisms of diseases, paired with medical expertise and global operations, enable us to support demands in Allergy/immunology, Dermatology, Gastroenterology, Ophthalmology, and Rheumatology.

• Learn more

• Neuroscience

• Enormous advances in the understanding of how the brain works and development of treatment modalities are cause for great hope for millions of people affected by neurological disorders. Our expertise covers all indications across neurology and psychiatry.

• Learn more

• Oncology

• We support treating all major types of cancer, across every phase of development, and the following indications: Benign and malignant hematology, Breast and gynecological cancers, GI cancers, Genitourinary cancers, Lung and head-and-neck cancer, Phase I and rare tumors.

• Learn more

• Pediatrics

• Our dedicated team of pediatric experts brings a patient- and family-centered approach to protocol development and study conduct to improve participation, accommodate patients’ needs, and successfully support trials from start to finish.

• Learn more

• Rare Diseases

• Our best-in-class team of rare disease experts are ready to tackle even the most complex trials with their clinical and regulatory expertise, while seamlessly aligning a study with the journey of the patient and caregiver.

• Learn more

• Parexel Academy

• Whether you are getting started in the biopharmaceutical industry, a seasoned vet looking to keep growing your career, or somewhere in between, the Parexel Academy can support your professional development through our diverse array of learning solutions.

• Learn mo