Senior Associate PV (Aggregate)

Advity Research; Hyderabad; On-site; INR 800,000 - 1,200,000; Full time

Job summary

A healthcare research firm in Hyderabad is looking for an experienced pharmacovigilance specialist with at least 3-4 years in the field. The role includes managing safety reports and ensuring compliance with international regulations. Candidates should have excellent communication and organizational skills, and the ability to work independently or in a team. Responsibilities include preparing aggregate reports, conducting audits, and training team members. Competitive compensation and growth opportunities available.

Qualifications

• Minimum of 3-4 years of experience in pharmacovigilance including ICSR and aggregate reports.
• Extensive knowledge of medical terminology and clinical pharmacology.
• Sound knowledge of pharmacovigilance principles and regulatory requirements.

Responsibilities

• Manage preparation of PSURs, PBRERs and PADERs for assigned products.
• Prepare and update aggregate report calendars.
• Involve in internal and external audits and inspections.

Skills

English communication skills

Organizational skills

Time management

Teamwork

Independent work

Job description

• Minimum of 3-4 years of experience in pharmacovigilance including ICSR (from literature sources) and aggregate reports.
• Extensive knowledge of medical terminology, clinical pharmacology, patent treatment, diagnostic investigations and pathology.
• Sound knowledge of pharmacovigilance principles and international regulatory requirements related to drug and patient safety.
• Possess excellent communications skills with professional English speaking, writing, presenting skills and must be detailed oriented.
• Excellent organizational and time management skills.
• Ability to work effectively independently and within a team environment and across global teams.

Detailed Responsibilities

• Manage the preparation of aggregate safety reports such as PSURs, PBRERs and PADERs for assigned products including planning, preparation and finalization of reports.
• preparation of RMPs and signal management reports.
• Preparing and updating aggregate report calendars in accordance to competent regulatory authorities.
• Generating and reviewing of line listings and summary tabulations.
• Retrieving and reviewing of literature for inclusion in aggregate reports.
• Involve in internal and external audits and inspections.
• Plan, organize and Manage daily work to meet internal timelines.
• Interface with other functional groups, relevant stake holders as needed.
• Perform reconciliation with clients.
• Monitoring Health authority websites for latest updates.
• Initiate CAPA in case of any process non-conformance.
• Archiving of final documents in accordance to SOPs.
• Training other pharmacovigilance team associates on relevant company procedures, latest Regulations and Guidelines.
• Any other PV duties as assigned by the management from time to time.