Clinical Pharmacovigilance & Regulatory Writing Job @ Accenture
Accenture announces job opening for pharma candidates. B Pharma job opening 2022. B Pharma job vacancy 2022. Pharmacovigilance – Clinical & Regulatory Writing job opening 2022. Pharmacovigilance – Clinical & Regulatory Writing job opening 2022. Candidates with Master’s degree in pharma may apply for the job opening at Accenture.
Job Title: Associate-Pharmacovigilance
JOB NO. 203342
Skill required: Pharmacovigilance – Clinical & Regulatory Writing
Job Location: Bengaluru
Qualifications: Master of Pharmacy
Years of Experience: 1-3 years
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 reviewing and resolving discrepancies identified by the system or through manual checks 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, and 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 they looking for?
They 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.
Click Here To Apply Online
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