Sr. Pv Associate

Indivirtus Healthcare Services

3-5 years

Not Disclosed

Chandigarh Mohali

Openings: 10 Posted: May 7, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding,

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Position: Senior Pharmacovigilance (PV) Associate Location: Mohali / Chandigarh Experience: 3-5 years

Description:

Position Title: Senior PV Associate
Location: Mohali / Chandigarh
Experience: 3-5 years

Key Responsibilities:

Conducting pharmacovigilance activities in adherence to regulatory requirements and company procedures.
Overseeing case processing, including case intake, data entry, coding, assessment, and reporting.
Managing adverse event reports and ensuring timely submission to regulatory authorities.
Collaborating with cross-functional teams, including medical, regulatory, and quality assurance, to ensure compliance and accuracy of safety data.
Contributing to the development and implementation of pharmacovigilance processes and systems improvements.
Participating in internal and external audits and inspections related to pharmacovigilance activities.
Providing guidance and training to junior PV staff as needed.

Requirements:

Bachelor's degree in life sciences or related field.
Minimum 3 years of experience in pharmacovigilance or related field.
Strong understanding of pharmacovigilance regulations and guidelines.
Proficiency in relevant pharmacovigilance databases and software.
Excellent communication and interpersonal skills.
Ability to work independently and collaboratively in a fast-paced environment.
Attention to detail and accuracy in data management and reporting.

Preferred Qualifications:

Master's degree in life sciences or related field.
Experience in pharmaceutical or biotechnology industry.
Knowledge of drug safety surveillance and risk management principles.
Certification in pharmacovigilance (e.g., RAPS RAC, DIA PV Program).
Familiarity with international pharmacovigilance regulations (e.g., FDA, EMA, ICH).