Job Title:
Pharmacovigilance Specialist, Case Processing
Job Location:
India
Job Type:
Full-time
Posted On:
Posted 4 Days Ago
Job Requisition ID:
JR 6956
Company Overview:
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
Job Description:
Responsible for daily case processing of adverse event cases (clinical trial and/or post-marketed), including coding using MedDRA, determining seriousness and expectedness at the event and case level.
Responsibilities:
Perform case follow-up activities such as identification of information to be collected during follow-up.
Create and review case narratives.
Provide client notifications as required for case management.
Support and contribute to the development of training materials and training delivery.
Highlight areas of concern/discrepancies to the Principal PV Specialist, Case Processing and/or Manager, Case Processing when related to ICSRs.
Acquire and maintain an up-to-date knowledge of global safety regulations for medicines.
Peer reviews of cases for quality, consistency, and accuracy as needed.
Other duties as assigned.
Necessary Skills and Abilities:
Strong verbal, written, and interpersonal communication skills.
High level of accuracy and attention to detail.
Ability to identify and resolve problems in a timely manner.
Able to work independently and collaboratively in a multi-disciplinary team.
Excellent organization and prioritization skills; able to multitask.
Basic knowledge of Pharmacovigilance.
Educational Requirements:
Required: a Bachelor's degree in life sciences.
Preferred: advanced degree, RN, RPh, PharmD, or equivalent.
Experience Requirements:
Two years of related work experience.
Diversity and Inclusion:
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
Note:
ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.
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