Job Description

Skill required: Pharmacovigilance - Clinical & Regulatory Writing

Designation: Associate

Job Location: Bengaluru

Qualifications: Master of Pharmacy

Years of Experience: 1-3 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 Pharmaceuticals Processes vertical and help us with the processes to collect, monitor, research, assess and evaluate information on the adverse effects of medication with a view to identifying new information about hazards associated with medicines and consequently, prevent harm to patients. It also deals with the reviewing and resolving of discrepancies identified by the system or through manual checks as per guidelines. Employees under this span can also be responsible for a number of activities related to the design, development, and maintenance of Clinical Database objects.

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 produce variety of clinical documents throughout the lifecycle of a (potential) treatment, starting with describing and reporting data from clinical trials, through to preparing regulatory submission documents including post approval reports.

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
  • Agility for quick learning

Roles and Responsibilities

  • In this role, you are required to solve routine problems, largely through precedent and referral to general guidelines
  • Your expected interactions are within your team and direct supervisor
  • You will be provided detailed to a moderate level of instruction on daily work tasks and detailed instruction on new assignments and the decisions that you make that would impact your work
  • 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 required to help in the overall team's workload by managing your deliverables and help the team when required
  • You will be an individual contributor as a part of a team, with a predetermined focused scope of work.

Please note this role may require you to work in rotational shifts.



Qualifications

Master of Pharmacy

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All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.

Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process.

Accenture is committed to providing veteran employment opportunities to our service men and women.

COVID-19 update:  The safety and well-being of our candidates, our people and their families continues to be a top priority. Until travel restrictions change, interviews will continue to be conducted virtually. 

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