Skill required: Pharmacovigilance - Safety Writing
Designation: Senior Drug Safety Associate
Job Location: Chennai
Qualifications: Any Graduation/Any Graduation/Any Graduation/Any Graduation
Years of Experience: 3-5 years
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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:
- Ability to establish strong client relationship
- Ability to work well in a team
- Ability to manage multiple stakeholders
- Ability to meet deadlines
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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Our more than 600,000 people in more than 120 countries, combine unmatched experience and specialized skills across more than 40 industries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.