Safety Specialist

Location

Andhra Pradesh | India

Job description

• Performs day-to-day PV activities. May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.
• Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals.
• Maintains medical understanding of applicable therapeutic area and disease states.
• Reviews cases entered for quality, consistency, and accuracy, including review of peer reports.
• Prepares and maintains regulatory safety reports.
• Assists with routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations. Mentors less experienced staff.

Qualifications: 

Education and Experience:  Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Experince:

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. 

Knowledge, Skills and Abilities:

· General understanding of pathophysiology and the disease process
· Detailed knowledge of relevant therapeutic areas as required for processing AEs
· Strong critical thinking and problem-solving skills
· Good oral and written communication skills including paraphrasing skills
· Good command of English and ability to translate information into local language where required
· Computer literate with the ability to work within multiple databases
· Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel)
· Understanding the importance of and compliance with procedural documents and regulations
· Ability to handle and prioritize a variety of tasks and meet timelines with limited supervision
· Strong attention to detail
· Ability to maintain a positive and professional demeanor in complicated circumstances
· Effectively fit in within a team to attain a shared goal

Job tags

Salary