06 Aug
|
Accenture
|
Chennai
Skill required: Pharmacovigilance Services - Pharmacovigilance Drug Safety Surveillance
Designation: Pharmacovigilance Services Specialist
Qualifications:Bachelor of Pharmacy/Bachelor of Physiotheraphy/BSc. Nursing
Years of Experience:5 to 6 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 world
- s 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 Services involve the detection, assessment, and prevention of adverse effects related to pharmaceutical products. These services ensure the safety and efficacy of medications by monitoring and analyzing data from clinical trials, healthcare providers, and patients. The goal is to identify potential risks and take appropriate actions to protect patient health. They also help pharmaceutical companies comply with regulatory requirements. Effective pharmacovigilance services are essential for maintaining public trust in medications.
Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements.
What are we looking for Strong experience in Literature Monitoring and Surveillance for Pharmacovigilance activities.
Proficiency in identifying, reviewing, and processing Individual Case Safety Reports (ICSRs) from global and local literature sources.
Experience in conducting Benefit-Risk Assessments and evaluating safety information from published literature.
Knowledge of literature databases, literature screening methodologies, and regulatory requirements related to safety reporting.
Ability to assess scientific publications and identify reportable safety information in accordance with applicable pharmacovigilance guidelines.
Experience in Literature screening/processing.
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 recent 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,Bachelor of Physiotheraphy,BSc. Nursing
📌 Pharmacovigilance Services Specialist (Chennai)
🏢 Accenture
📍 Chennai