Skill required: Pharmacovigilance - Medical Affairs
Job Location: Bengaluru
Qualifications: Bachelor of Dental Surgery/Bachelor of Pharmacy
Years of Experience: 3-5 years
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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 Medical Affairs, you will have to design, develop and deliver business solutions related to the medical affairs group of pharmaceutical companies, including thought leadership development, medical publications, education and information, medical grants, advisory boards and advocacy, regulatory review and approval of pharmaceutical drugs and perform publishing and quality control tasks on submission components.
What are we looking for?
We are looking for individuals who have the following skillset:
- Adaptable and flexible
- Ability to perform under pressure
- Agility for quick learning
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.
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