Director, Safety Physician, Global Pharmacovigilance
, PA, United States
Our client's vision to transform the way we understand and treat the most challenging medical conditions of our time, including cancer, autoimmune disorders and infection.
The Safety Physician, Global Pharmacovigilance, should be a physician with training and experience in Pharmacovigilance and Risk Management in the pharmaceutical/biotech industry to contribute to the overall medical oversight and safety evaluation within Pharmacovigilance and Risk Management. This position is responsible for the proactive and timely risk-benefit assessments of safety data to characterize the emerging and known safety profiles of development and marketed company products. The Safety Physician assists in the successful development, execution and maintenance of safety-related strategies, processes and systems that conform to the company's business strategy, industry standards and compliance with global regulations. This individual will provide guidance to third party vendors and to internal/external staff in the collection, evaluation and processing of adverse events from clinical trials and postmarketing surveillance. This role provides an excellent opportunity to collaborate closely with colleagues from other functions such as Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs.
Job Responsibilities
Conduct medical review of individual case safety reports (ICSRs) including identification of appropriate follow-up requests of important medical information for the proper medical assessment and evaluation of cases.
Responsible for the review and communication of safety data trending, signalling and other safety related issues originating from any source for the purpose of detecting and reviewing safety signals in a timely manner via the Safety Governance process.
Responsible for the development of review/response documents for safety issues arising from internal review or regulator feedback.
Chair the multidisciplinary Safety Management Team whose responsibilities include safety surveillance (signal detection and evaluation), risk management planning, and making recommendations related to safety issues
Participate in the preparation and maintenance of Reference Safety Information (RSI) and product labeling (e.g. Company Core Safety Information (CCSI), Investigator Brochure (1B), national labels), Risk Management Plans (RMP).
Collaborate with key stakeholders including business partners in appropriate safety analyses and risk assessment and management strategies.
Author medical-safety sections of aggregate safety reports (DSUR, PBRER)
Participate in development of safety-related responses to queries from Regulatory Authorities
Maintain knowledge of disease and therapeutic areas for marketed products and products in development
Demonstrate knowledge and ensure compliance with applicable global PV regulations and guidelines (e.g. CIOMS, FDA, EMA, ICH, etc.).
Job Requirements
M.D./D.O Degree
Experience in Pharmacovigilance, particularly with individual case review and evaluation.
Experience with concepts of signal detection and review of aggregate data to identify potential emerging safety issues, benefit risk assessment, and risk management strategies.
Knowledge of clinical development process
Experience in the preparation and contribution to authoring of aggregate safety reports for regulator submission.
Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality.
Experience with commercially available safety databases.
At least three years of practical clinical experience post licensure
At least three years of pharmacovigilance experience
Knowledge of drug approval process in major countries.
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