Pharmacovigilance Services Specialist

Accenture PLC

Bengaluru

On-site

INR 900,000 - 1,500,000

Full time

5 days ago
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Job summary

Accenture PLC is seeking a Pharmacovigilance Services Specialist aligned with Life Sciences R&D. The role focuses on pharmacovigilance operations, safety surveillance, and regulatory compliance, requiring 7–11 years of experience and a B.Pharm/M.Pharm background.

You will engage in case processing, MedDRA coding, and safety data management, contributing to client projects across global regulatory requirements, with potential rotational shifts.

Qualifications

  • Experience in pharmacovigilance operations and drug safety processes.
  • Ability to analyze moderately complex problems and derive solutions.
  • Strong understanding of regulatory requirements related to pharmacovigilance.

Responsibilities

  • Perform case identification, data entry, MedDRA coding and case processing.
  • Support submission and follow-ups for safety reports.
  • Maintain safety databases per client guidelines and global regulations.
  • Collaborate with senior management to align with team goals.
  • Interact with peers and client teams; may manage small project teams.
  • Prepare analyses and contribute to safety surveillance activities.
  • Possibly work in rotational shifts as required.

Skills

Pharmacovigilance
Data analysis

Education

Bachelor of Pharmacy
Master of Pharmacy

Job description

Skill required:

Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance

Designation:

Pharmacovigilance Services Specialist

Qualifications:

Bachelor of Pharmacy/Master of Pharmacy

Years of Experience:

7 to 11 years

Intelligent Operations centers. Our 784,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries.

What would you do

You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Pharmacovigilance Operations involve monitoring and assessing the safety of pharmaceutical products. This includes detecting, evaluating, and preventing adverse effects or any other drug-related problems. The goal is to ensure that medications are safe for patients and to comply with regulatory requirements. These operations involve collecting and analyzing data from clinical trials, healthcare providers, and patients. Effective pharmacovigilance is crucial for protecting public health and maintaining trust in medical products.

Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for IC

Srs in the safety database as per client guidelines and applicable global regulatory requirements.

What are we looking for

looking for a Senior Drug Safety Scientistlooking for a Senior Drug Safety Scientist

Roles and Responsibilities:
  • In this role you are required to do analysis and solving of moderately complex problems
  • May create new solutions, leveraging and, where needed, adapting existing methods and procedures
  • The person would require understanding of the strategic direction set by senior management as it relates to team goals
  • Primary upward interaction is with direct supervisor
  • May interact with peers and/or management levels at a client and/or within Accenture
  • Guidance would be provided when determining methods and procedures on new assignments
  • Decisions made by you will often impact the team in which they reside
  • Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture
  • Please note that this role may require you to work in rotational shifts
Qualification

Bachelor of Pharmacy,Master of Pharmacy

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