Pharmacovigilance Services Analyst-Pharmacovigilance

3-5 years

Not Disclosed

Chennai

12 May 24, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Senior Drug Safety Associate
Skill Required: Pharmacovigilance - Safety Writing
Job Location: Chennai
Qualifications: MSc/Bachelor of Pharmacy/Master of Pharmacy
Years of Experience: 3 to 5 years

About Accenture: Accenture is a global professional services company with leading capabilities in digital, cloud, and security. Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song—all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners, and communities. Visit us at www.accenture.com.

What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services to pharmacovigilance and patient services solutions. Employees in this span will be part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies improve outcomes by converging around the patient and connecting scientific expertise with unique insights into the patient experience.

Key Responsibilities:

Work within a dynamic Pharmacovigilance team with a range of capabilities from detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine-related problem following Good Pharmacovigilance Practice (GVP) per client SOPs and applicable global regulatory requirements.
Handle Individual Case Safety Reports.
Engage in various aspects of Aggregate reports such as planning, authoring, reviewing, and publishing PBRER, PSUR, DSUR, PADER, Addendum to clinical overview (AdCO), Risk Management Plan (RMP), Signal detection and validation reports (SDVR), and Cosmetovigilance Safety Reports (CoSR).
Author and review clinical documents such as Protocols and amendments, Investigator Brochure, Clinical Study Reports (CSR), Synoptic/Abbreviated CSR, Safety Narratives, and Clinical Overview/abbreviated Clinical Overview.
Manage and develop individual case narratives describing adverse events for inclusion in regulatory submissions and safety reports for completed/interim clinical study reports.

What are we looking for?

Ability to establish strong client relationships
Ability to perform under pressure
Adaptable and flexible
Problem-solving skills
MSc in Life Sciences

Roles and Responsibilities:

Analyze and solve lower-complexity problems.
Interact day-to-day with peers within Accenture before updating supervisors.
Limited exposure to clients and/or Accenture management.
Receive moderate-level instruction on daily work tasks and detailed instructions on new assignments.
Make decisions that impact your own work and may impact the work of others.
Function as an individual contributor as part of a team with a focused scope of work.

Additional Information:

This role may require you to work in rotational shifts.

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