7 July, 2022
Accenture is Hiring Senior Drug Safety Associate
Skill required: Pharmacovigilance – Pharmacovigilance & Drug Safety Surveillance
Designation: Senior Drug Safety Associate
Job Location: Mumbai
Qualifications: Any Graduation
Years of Experience: 3-5 years
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 are required to analyze and solve lower-complexity problems
Your day to day interaction is with peers within Accenture before updating supervisors
You may have limited exposure with clients and/or Accenture management
You will be given moderate level instructions on daily work tasks and detailed instructions on new assignments
You will need to be well versed with basic statistics and terms involved in the day to day business and use it while discussing with stakeholders
You will be expected to constantly be on the lookout for ways to enhance value for your respective stakeholders/clients
The decisions you make impact your work and may impact the work of others
You will be an individual contributor as a part of a team, with a focused scope of work.
Please note this role may require you to work in rotational shifts.