Pharmacovigilance Specialist

PPG US ProPharma Group, LLC; Hyderabad; Hybrid; INR 600,000 - 900,000; Full time

Job summary

PPG US ProPharma Group, LLC in Hyderabad, India, seeks a Pharmacovigilance Case Processor to manage daily adverse event case processing, coding with MedDRA, and determination of seriousness and expectedness at the event and case level.

You will follow up to collect information, create and review narratives, and issue client notifications. The role requires two years PV experience, a life sciences degree, and strong communication and attention to detail.

Qualifications

• Bachelor's degree in life sciences required.
• Advanced degree or healthcare professional background preferred.
• Two years of related PV experience.
• Knowledge of global safety regulations.
• Strong communication and organizational skills.

Responsibilities

• Process daily adverse event cases using MedDRA and assess seriousness at event and case level.
• Perform follow-up to collect information needed for case completion.
• Create and review case narratives.
• Provide client notifications for case management.
• Develop and deliver training materials as needed.
• Identify discrepancies and raise with PV leads.
• Maintain up-to-date knowledge of global safety regulations.
• Peer review of cases for quality and accuracy.
• Support other duties as assigned.

Skills

Communication skills

Attention to detail

Problem solving

Independence

Organization

Education

Bachelor's degree life sciences

Advanced degree RN/RPh/PharmD

Tools

MedDRA

Job description

Essential Functions

• 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.
• Perform case follow up activities such as identification of information to be collected during follow-up.
• Creating and reviewing case narratives.
• Providing client notifications as required for case management.
• Supporting and contributing 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 IC SRs.
• 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.

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.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in-person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.

ProPharma will never ask you for any bank account information, financial information, or another form of payment to be considered for a role.

Additionally, the ProPharma talent acquisition team will only use their work email addresses ([e-mail]).

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