ProPharma Group, a global leader in regulatory sciences, clinical research, and pharmacovigilance, is seeking a Pharmacovigilance Specialist (Case Processing) to join their dynamic team. With over 20 years of experience, ProPharma partners with biotech, medical device, and pharmaceutical companies to ensure safe and effective therapies reach patients worldwide.
Key Responsibilities:
- Process adverse event (AE) cases (clinical trial and post-marketed), including MedDRA coding, assessing seriousness, and determining expectedness.
- Conduct case follow-up activities to gather additional information as needed.
- Write and review case narratives for accuracy and completeness.
- Notify clients regarding case management updates as required.
- Assist in developing training materials and conducting training sessions.
- Identify and escalate discrepancies to senior team members.
- Perform peer reviews of cases for quality and consistency.
- Stay updated on global pharmacovigilance regulations and guidelines.
Required Skills & Qualifications:
- Bachelor’s degree in Life Sciences (Pharmacy, Nursing, Medicine, or related field).
- 2+ years of pharmacovigilance experience (case processing preferred).
- Strong knowledge of MedDRA coding and drug safety regulations.
- Excellent verbal and written communication skills.
- High attention to detail and ability to manage multiple tasks efficiently.
- Ability to work independently and collaboratively in a team.
Preferred Qualifications:
- Advanced degree (PharmD, RN, RPh, or equivalent).
- Experience in clinical trial/post-marketing safety case processing.
- Familiarity with Argus, ARISg, or other safety databases.
About ProPharma Group
ProPharma Group is a trusted partner for pharmaceutical, biotech, and medical device companies, offering end-to-end solutions in:
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- Regulatory Affairs
- Clinical Research
- Pharmacovigilance & Drug Safety
- Medical Information
- Quality & Compliance
With a commitment to diversity, equity, and inclusion, ProPharma fosters an innovative and supportive workplace where employees can thrive.
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