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Vizen Life Sciences Hiring for Pharmacovigilance | Case Processing, PSUR, Quality Review and Submissions

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Vizen Life Sciences

B.Pharm / M.Pharm / Pharm.D / BDS / Relevant Degree

Hyderabad

2โ€“10 years

Verified Job

Online Application
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Vizen Life Sciences has announced multiple Pharmacovigilance jobs in Hyderabad for experienced pharmacy professionals. The company is recruiting for three key PV functions: Case Processing Associate, Quality Review and Submissions (ICSR), and PSUR/PADER/Signal Draft.

These Vizen Life Sciences jobs are suitable for candidates with qualifications including D.Pharm, B.Pharm, M.Pharm and Pharm.D, depending on the position. The openings cover important drug safety functions such as ICSR case processing, MedDRA coding, Oracle Argus, regulatory submissions, aggregate reporting, PSUR/PBRER, PADER, RMP and signal management.

A total of 20 openings were indicated across the three listings, with experience requirements ranging from 2 to 10 years.

Vizen Life Sciences Job Openings 2026

ParticularDetails
CompanyVizen Life Sciences
IndustryPharmaceutical & Life Sciences
DepartmentPharmacovigilance / Drug Safety
RolesCase Processing Associate; Quality Review & Submissions (ICSR); PSUR/PADER/Signal Draft
LocationGachibowli, Hyderabad, Telangana
EmploymentFull Time, Permanent
Experience2โ€“10 years depending on role
QualificationsD.Pharm / B.Pharm / M.Pharm / Pharm.D depending on role
Total Openings20
SalaryNot disclosed by employer
Application ModeOnline

1. Case Processing Associate

Vizen Life Sciences is hiring Case Processing Associates with hands-on pharmacovigilance experience. This position primarily involves processing Individual Case Safety Reports (ICSRs), evaluating case validity, coding adverse events and maintaining accurate safety data.

Experience: 2โ€“7 years
Qualification: B.Pharm / M.Pharm / Pharm.D
Openings: 10

Key Responsibilities

  • Conduct duplicate searches and identify potentially duplicate safety cases.
  • Assess ICSR validity, completeness and relevance.
  • Perform accurate coding of suspect medicinal products.
  • Conduct MedDRA coding of adverse events and medical information.
  • Assess and document seriousness according to applicable regulatory requirements.
  • Perform case book-in for spontaneous, literature and E2B cases.
  • Enter ICSR information accurately into the safety database.
  • Process cases received from literature, health authorities, clinical trials and spontaneous sources.
  • Conduct peer review and data reconciliation to verify case accuracy and completeness.
  • Resolve discrepancies identified during ICSR processing.
  • Coordinate with other ICSR teams, PV functions, IT teams and external vendors.
  • Monitor case-processing quality, productivity and timeliness metrics.
  • Support process improvement and standardization initiatives.
  • Assist with audits, inspections and CAPA-related activities.

Skills Required

Candidates should have practical knowledge of pharmacovigilance case processing, MedDRA, drug safety, ICSR processing and Oracle Argus or comparable safety databases.

Strong analytical, problem-solving, literature-search and written/verbal communication skills are also important.


2. Quality Review and Submissions (ICSR)

The Quality Review and Submissions (ICSR) position focuses on quality control and timely regulatory reporting of safety cases to Health Authorities and other applicable stakeholders.

Experience: 5โ€“10 years
Qualification: D.Pharm / B.Pharm / M.Pharm
Openings: 5

Key Responsibilities

  • Review, approve and schedule regulatory reports in the Oracle Argus database.
  • Submit ICSRs to applicable Health Authorities.
  • Coordinate safety-case submissions to business partners and affiliates.
  • Ensure compliance with internal and external pharmacovigilance timelines.
  • Schedule regulatory reports according to applicable reporting obligations.
  • Perform ICSR quality review before regulatory submission.
  • Maintain compliance with pharmacovigilance regulations and submission requirements.
  • Ensure accurate and timely completion of regulatory reporting activities.

Skills Required

Applicants should have substantial experience in ICSR Quality Review and Regulatory Report Submissions, along with hands-on knowledge of Oracle Argus.

Knowledge of global PV regulations, Health Authority reporting requirements, quality assurance and regulatory compliance is essential. Attention to detail, analytical ability, communication and time management are also important for this position.


3. PSUR / PADER / Signal Draft

This opening covers advanced aggregate reporting and signal management responsibilities. Candidates should have experience with PSUR/PBRER, PADER, RMP preparation or pharmacovigilance signal activities.

Experience: 3โ€“8 years
Qualification: D.Pharm / B.Pharm / M.Pharm
Openings: 5

PSUR & RMP Responsibilities

  • Author and review PSURs/PBRERs and Risk Management Plans (RMPs).
  • Ensure accuracy, completeness and regulatory compliance of aggregate safety reports.
  • Perform literature searches for PSUR and RMP preparation.
  • Validate relevant safety information obtained from literature.
  • Extract and validate information from Reference Safety Information, sales data, previous reports and RMPs.
  • Generate line listings from safety databases.
  • Maintain process trackers and ensure activities remain on schedule.
  • Coordinate with clients and internal stakeholders regarding PSUR-related queries.
  • Support high-priority and ad-hoc aggregate reporting activities.
  • Provide subject-matter expertise and training to team members.

PADER Responsibilities

  • Draft Periodic Adverse Drug Experience Reports (PADERs) according to reporting schedules.
  • Prepare relevant line listings and tabulations.
  • Maintain the PADER reporting calendar.
  • Coordinate with cross-functional teams to obtain required inputs.
  • Resolve queries and discrepancies before report finalization.
  • Archive PADER documentation appropriately.
  • Complete reports within applicable internal and regulatory timelines.
  • Prepare or review SOPs and work instructions aligned with relevant GVP and FDA requirements.
  • Train junior associates on PADER processes.
  • Support audits and regulatory inspections.

Signal Management Responsibilities

  • Perform pharmacovigilance signal detection and triage.
  • Review individual case reports and aggregate safety data to identify potential new safety signals.
  • Conduct medical and scientific evaluation of signal-detection outputs.
  • Present findings during safety review and cross-functional meetings.
  • Collaborate with product safety leads and Signal Management Teams.
  • Conduct searches in external safety databases such as FAERS, VigiBase, iDAP and DAEN.
  • Perform QC of Health Authority database searches.
  • Support EudraVigilance monitoring activities.
  • Train and mentor junior signal-management colleagues.
  • Contribute to SOPs, guidance documents and improved signal-detection methodologies.

Who Can Apply?

Candidates with the following educational backgrounds may be considered depending on the specific role:

D.Pharm, B.Pharm, M.Pharm and Pharm.D.

For the Case Processing Associate opening, the job description specifically highlights B.Pharm, M.Pharm and Pharm.D candidates.

These are experienced-candidate openings rather than fresher vacancies. The minimum stated experience is 2 years for Case Processing Associate, 3 years for PSUR/PADER/Signal Draft and 5 years for Quality Review & Submissions.

Why Consider These Pharmacovigilance Roles?

These openings provide exposure to several specialized areas of pharmacovigilance, including:

  • ICSR processing and quality review
  • MedDRA coding
  • Oracle Argus
  • Global regulatory submissions
  • Aggregate reporting
  • PSUR/PBRER and PADER authoring
  • Risk Management Plans
  • Signal detection and management
  • Health Authority safety databases
  • PV compliance, audits and CAPA

Professionals looking to deepen their careers in drug safety, ICSR operations, aggregate reporting or signal management may find these positions particularly relevant.

How to Apply

Application Link For Quality Review and Submissions (ICSR)

Application Link For PSUR / PADER / Signal Draft

Application Link For Case Processing Associate

careers@vizenlifesciences.com

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