Pharmacovigilance Services Specialist

Accenture PLC; Mumbai; Sur place; INR 1 800 000 - 2 400 000; Plein temps

Résumé du poste

Accenture PLC in Mumbai (India) seeks a Pharmacovigilance Services Specialist with 7–11 years of experience in drug safety surveillance to join the Life Sciences RD vertical. The role focuses on PV operations, case processing, and regulatory compliance across global guidelines.

You will handle MedDRA coding, data entry, and safety submissions, while aligning with senior management on strategy and delivering client-focused pharmacovigilance solutions.

Qualifications

• Experience in pharmacovigilance operations and safety surveillance.
• Understanding of regulatory requirements for drug safety data.
• Knowledge of adverse event case handling and MedDRA coding.

Responsabilités

• Analyze and solve moderately complex pharmacovigilance problems.
• Develop new methods or adapt existing ones for safety surveillance.
• Align with senior management on team goals and direction.
• Interact with supervisor, peers, and client teams as needed.
• Provide guidance on methods and procedures for new assignments.
• Make decisions impacting the team and project outcomes.
• Possibly lead small teams or work efforts at client sites.
• Work in rotational shifts as required.

Connaissances

Pharmacovigilance

Drug Safety

Formation

Bachelor of Pharmacy

Master of Pharmacy

Description du poste

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

What would you do

You will be aligned with our Life Sciences RD 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 ICSSRS in the safety database as per client guidelines and applicable global regulatory requirements.

What are we looking for

Looking for a Senior Drug Safety Scientist

Looking 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