Assistant Manager - Pharmacovigilance Services
Skill required: Pharmacovigilance - Pharmacovigilance & Drug Safety Surveillance
Designation: Assistant Manager - Pharmacovigilance Services
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 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 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.
You will be part of a dynamic Pharmacovigilance team with array of capabilities ranging 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 (Individual Case Safety Reports) to working on various aspects of Aggregate reports such as planning, authoring, reviewing and publishing of PBRER, PSUR, DSUR, PADER, Addendum to clinical overview (AdCO), Risk Management Plan (RMP), Signal detection and validation reports (SDVR), Cosmetovigilance Safety Reports (CoSR). The Pharmacovigilance team is also responsible for authoring and reviewing clinical documents such Protocols and amendment, Investigator Brochure, Clinical Study Reports (CSR), Synoptic/Abbreviated CSR, Safety Narratives, Clinical Overview/abbreviated Clinical Overview.
In this role, you will be expected to 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
We are looking for individuals who have the following skillset:
Adaptable and flexible
Ability to perform under pressure
Ability to establish strong client relationship
Roles and Responsibilities
In this role, you need to analyze and solve increasingly complex problems
Your day to day interactions is with peers within Accenture
You are likely to have some interaction with clients and/or Accenture management
You will be given minimal instruction on daily work/tasks and a moderate level of instructions on new assignments
You will need to consistently seek and provide meaningful and actionable feedback in all interactions
You will be expected to be constantly on the lookout for ways to enhance value for your respective stakeholders/clients
Decisions that are made by you will impact your work and may impact the work of others
You would be an individual contributor and/or oversee a small work effort and/or team.
Please note this role may require you to work in rotational shifts.