14 March, 2022
Experience in drafting PSUR, PBRER, DSUR, CSR, Cosmetic Safety Reports, ASR, SMR, RMP, REMS, Signal Validation Reports and Literature Screening.
About the job
Skill required: Pharmacovigilance – Safety Writing
Designation: Assistant Manager – Pharmacovigilance Services
Job Location: Bengaluru
Qualifications: Any Graduation
Years of Experience: 5-8 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 manage and develop individual case narratives describing adverse events for inclusion in regulatory submissions and safety reports for completed/interim clinical study reports.
What are we looking for?
We are looking for individuals who have the following skillset:
Adaptable and flexible
Ability to establish strong client relationship
Ability to work well in a team
Ability to meet deadlines
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.
Apply through below link: