Who we are
Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What the Pharmacovigilance Department Does at Worldwide
Pharmacovigilance is the gateway to ensuring drug safety! Our Pharmacovigilance team comprises a dynamic group of individuals with extensive experience within the Drug Safety world. From watching drugs progress from First in Human Administration to global regulatory approval, we can be a part of the entire lifecycle of a compound making it to the market. We review safety events from all over the world and work with our clients to review, analyze, and submit to Investigators, Ethics Committees/IRBs, and Regulatory Agencies furthering clinical drug development! This role is responsible for providing medical and scientific support to the Pharmacovigilance department in accordance with applicable regulatory guidelines/requirements, Worldwide Standard Operating Procedures (SOPs) and project specific instructions. Primary responsibilities include regulatory assessment of reported serious adverse events, medical review of serious adverse events, medical training of PV staff and/or team and safety surveillance and signal detection/analysis.
What you will do
Accountable and responsible for the medical review, analysis and approval of all individual Serious Adverse Event and Serious Adverse Reaction reports. Provide guidance during the case handling and reporting cycle. Determine seriousness, listedness, causality, and summarize Sponsor position for single case reports. Perform analysis of similar events
Lead the preparation of aggregate safety reports (DSURs), case narratives and any other safety medical documentation thus contributing to high quality standard documents within the organization
Carry out continuous efficient evaluation of adverse event and all other safety information to predict and manage the safety profile of compounds in clinical development through identifying the need for updates to the reference safety information and drive proactive implementation of risk management initiatives in accordance with global regulatory requirements
Provide medical guidance and training to Drug Safety Associates in medical aspects of drug safety as well as to Medical Monitoring teams. Provide medical advice and support for the Pharmacovigilance component of feasibility studies
Inform the appropriate Medical Monitor of any new SUSAR or medically significant new information that might impact on the safety profile of the medicine. Liaise with Medical Monitoring teams in projects requiring drug safety and medical monitoring services ensuring safety information is characterized and managed
Work with Business Development staff to assist in the acquisition of new work. May participate in business development activities such as presenting at conferences, participating in marketing efforts, authoring white papers, etc.
What you will bring to the role
Strong understanding of serious adverse event medical review, assessment and reporting process
Excellent organization skills and ability to handle multiple competing priorities within tight timelines
Consistently demonstrates commitment, dependability, cooperation, adaptability and flexibility in executing daily tasks and responsibilities. Ability to anticipate needs and follow through on all assigned tasks
Able to work well independently, but also able to seek input effectively from others when appropriate. Makes sound decisions within the scope of responsibility. Focuses on solutions and problem resolution verses complaining or placing blame
Your background
Medical Degree from an accredited institution of Medical Education
Minimum of 3 years clinical research or industry experience with at least 2 years of experience serving as a PV Physician
Demonstrated ability to handle multiple competing priorities while adhering to applicable timelines.
Ability and willingness to travel domestically and internationally if needed to support project meetings, bid defenses and/or provide support for business development efforts
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at www.worldwide.com/careers ! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
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