This is a rare opportunity to join a young, exciting science driven pharmaceutical company.
Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drug compounds at an advanced stage in research. The company has a newly created vacancy for an experienced Pharmacovigilance Scientist.
The Pharmacovigilance Scientist (PVS) is an experienced scientist who provides pharmacovigilance expertise for deliverables and activities associated with signal detection, safety and benefit-risk evaluations for our clients' products, management of potential safety issues, evaluation of databases for safety signals, and drafting of responses to regulatory inquiries on product safety issues.
Clinical Trial Safety:
? Review study protocols, statistical analysis plans, and other clinical study-related documents
? Review standard design of tables, figures and listings for safety data from clinical studies.
? Contribute to the assessment of clinical trial vendors for outsourcing projects and communicates business needs effectively to PV management
o Performs detailed vendor oversight activities including review of metrics, and deliverables from vendor
o Reviews, documents, and escalates concerns and issues to PV management
Signal Detection, Evaluation, and Management:
? Performs proactive safety monitoring and signal detection
? Completes initial assessment of safety signals and prioritizes safety signals for full evaluation
? Draft the evaluation and prepare response documents of safety signals to answer internal and/or external requests
? Perform case series review or review of tabulated data and prepare interpretation of reviewed data
Risk Management and Minimization:
? Draft section(s) of the Risk Management Plan (RMP) and/or Risk Evaluation and Mitigation Strategies (REMS), oversee the maintenance of these documents, and provide oversight/coordination of the implementation of the RMP/REMS requirements
Periodic (Aggregate) Safety Reporting:
? Provide input into the preparation and coordination of aggregate reports (i.e., PSUR, DSUR, IND annual, NDA annual, etc.) for submission to the health authorities and other stakeholders
Submissions and other regulatory filings
? Assist in the preparation of safety assessments and evaluations for ad hoc regulatory safety reports such as responses to health authorities' requests, Health Hazard Evaluation, and responses to inquiries from internal and external customers
- Provides PV input to the development of product Reference Safety Information (Core Company Safety Information, US Package Insert, Developmental Core Safety Information, Investigators Brochure, etc.), Summary of Clinical Safety, Integrated Summary of Safety, etc. in collaboration with the PV physician
- Pharmacy degree with 2year PV experience, or MS in health-related field or BSN with 3 or more years PV experience, or BS in life sciences related field with 5 or more years PV experience.
? In depth knowledge of global clinical and post marketing safety regulations, guidance's, and reporting processes
? Must be detail-oriented and must have strong organizational and communication skills
? Experience with MedDRA coding and ARGUS safety database system
Preferred Qualifications and Experience:
? At least 3 years of biotech/pharmaceutical industry experience, including at least 2 years of experience in clinical safety / Pharmacovigilance.
? 2-3 years relevant clinical safety, regulatory, or risk management experience strongly preferred
? Knowledge and experience with safety surveillance, signal detection, labeling analyses, and ad hoc safety analyses.
? Experience in the reviews of relevant safety information from all sources and analysis of safety data.
? Experience with development, authorship and review of aggregate reports (i.e., PSUR, DSUR, IND annual, NDA annual, etc.), Risk Management Plans, and Risk Evaluation and Mitigation Strategies
- Ability to leverage a deep understanding of oneself through knowing one's strengths and weaknesses, proactively asking for feedback to balance self-perception, and being resilient to increase one's effectiveness.
- Ability to recognize opportunities and/or issues and applying analytical and creative thinking to maximize performance.
- Ability to focus on delivering excellent results and improving the performance of oneself by taking initiative to try new approaches, while still following the rules (e.g., company, government and ethical), by taking action to surpass one's own past performance, excel at an objective measure or goal, or do something that has never been done before.
- Ability to work cooperatively with colleagues and take initiatives to build relationships despite differences in interest, offering support and help to peers without being asked or proactively seeking input from others to solve problems.
- Ability to express ideas and information clearly and accurately. Excellent interpersonal, communication, and personal organization skills;
- Ability to targeting one's efforts on discovering and meeting an internal or external customer's needs by ensuring timely follow through to customer inquiries or business issues, and being proactive in adding value to the customer.
- This position that requires significant interactions with internal colleagues from other departments and with external colleagues and consultants.
- Minimal travel may be required
Cv to firstname.lastname@example.org 01 2302400