Safety Specialist

3 weeks ago

Cochin, Kerala, India Thepharmadaily Full time
Job Description

As a Safety Specialist, you will be responsible for performing daily PV activities within a regulated environment, including:

- Monitoring, collecting, translating, disseminating, and tracking safety information
- Serving as a regulatory authority contact point
- Supporting global PV operations with data entry, coding, adverse event assessment, follow-up, tracking reports, and regulatory reporting activities
- Collaborating with project team members, client contacts, reporters, and third-party vendors
- Assisting in preparing departmental and project-specific procedures and processes
- Preparing for and attending meetings, audits, and regulatory authority inspections

This role offers an opportunity to advance your PV career while gaining exposure to both post-approval and clinical trial settings.

A Day in the Life

- Perform daily PV activities
- Participate in on-call duties for 24-hour coverage for regulatory authority calls
- Review regulatory/pharmacovigilance publications and information sources to stay updated on current regulations, practices, and procedures
- Review cases for quality, consistency, and accuracy
- Prepare and maintain regulatory safety reports
- Assist with routine project implementation and coordination, including presentations at client meetings and review of metrics and project budgets
- Mentor less experienced staff

Education

- bachelors degree or equivalent formal academic/vocational qualification
- Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
- In some cases, a combination of education, training, and/or directly related experience will be considered sufficient

Knowledge, Skills, Abilities

- Strong critical thinking and problem-solving skills
- Good oral and written communication skills, including paraphrasing
- Good command of English and ability to translate information to/from the local language
- Computer literate with the ability to work within multiple databases
- Previous exposure to Microsoft Office packages (Outlook, Teams, Word, Excel, PowerPoint)
- Understanding the importance of and compliance with procedural documents and regulations
- Ability to manage and prioritize tasks and meet strict deadlines with limited supervision
- Strong attention to detail
- Ability to maintain a positive and professional demeanor in challenging circumstances
- Ability to work effectively within a team to achieve a shared goal

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