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Senior Associate, Pharmacovigilance - Us - Remote

5+ years
Not Disclosed
10 Jan. 9, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Lead Pharmacovigilance Associate - Serious Adverse Event (SAE) Reporting

About Us:
We are Worldwide Clinical Trials, a global, midsize CRO dedicated to pushing boundaries, innovating, and finding creative solutions to the world’s most persistent diseases. With over 3,500 experts on our team, we are transforming the way the world experiences CROs for the better. Together, we are working toward improving lives and offering new opportunities for patients and their caregivers.

Why Worldwide Clinical Trials:
At Worldwide, we believe everyone plays a vital role in making a significant impact on patients' lives. Our diverse and inclusive environment empowers professionals of all backgrounds and experiences to succeed. We foster a collaborative and creative culture where our teams thrive by being themselves and are inspired to do their best work every day.

Job Summary:
The Lead Pharmacovigilance Associate is responsible for the collection, processing, evaluation, and reporting of incoming Serious Adverse Event (SAE) data in compliance with regulatory requirements, Worldwide Standard Operating Procedures (SOPs), and project-specific instructions. This role leads large-scale and complex studies with minimal supervision, providing mentorship and guidance to junior staff.

Key Responsibilities:

  • Independently lead and perform tasks such as authoring Safety Management Plans and attending internal and client meetings.
  • Review SAE data for completeness and accuracy, enter data into safety databases, and resolve queries.
  • Conduct quality control of processed SAEs and generate regulatory reports as required.
  • Prepare and submit periodic safety reports and maintain knowledge of safety-related regulations and guidelines.
  • Assist with project budget and scope understanding, ensuring compliance with agreed-upon work.
  • Mentor and train new Pharmacovigilance staff, and contribute to bid defenses or other presentations.
  • Other duties as assigned.

Other Skills and Abilities:

  • Strong understanding of medical/scientific terminology, clinical assessment of adverse events, and international regulations.
  • Excellent organizational and communication skills, with the ability to handle multiple competing priorities.
  • Ability to interact diplomatically and professionally with both internal and external global customers.
  • Demonstrates adaptability, dependability, and flexibility in completing tasks, while focusing on solutions.

Requirements:

  • Bachelor’s degree in a science-related field, nursing, or equivalent.
  • Minimum of 5 years of pharmacovigilance experience (pre-approval clinical trials).
  • Strong computer skills, particularly in MS Office applications (Excel, PowerPoint, Word).
  • Fluent in written and verbal English.
  • Ability to work independently and in matrix teams, and to manage multiple priorities.
  • Willingness for limited domestic and international travel as needed.

Why Join Us:
At Worldwide Clinical Trials, we know the work we do improves lives, and we are proud of the impact we make. If you’re passionate about making a difference and collaborating with a diverse, innovative team, we invite you to join us.

To Apply:
Explore more opportunities on our careers page and discover how you can make a world of difference with Worldwide Clinical Trials. Visit www.Worldwide.com or connect with us on LinkedIn.

Worldwide is an equal opportunity employer committed to creating an inclusive environment where all employees have equal opportunities for success. We encourage applicants from all backgrounds and experiences.