Safety Data Associate Job

SAFETY DATA ASSOCIATE needed for a contract opportunity with Yoh's client located in Whippany, NJ

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- The Safety Data Associate, US Pharmacovigilance (PV) case processing role is responsible for triaging and prioritizing serious and non-serious adverse events received from all sources including, but not limited to physicians, investigators, pharmacists, nurses, consumers, patients, CROs (Contract Research Organizations), per FDA (Food and Drug Administration) regulatory guidelines and SOPs (Standard Operating Procedures).

WHAT YOU'LL BE DOING:

- The immediate and accurate prioritization of all incoming US serious and non-serious adverse event reports is critical for the company to maintain compliance with local and international regulations.
- The Safety Data Associate will work in close collaboration with the Manager, Country PV Information Processing as well as the case processing team to ensure compliance with regulatory reporting timelines and changes in regulations pertaining to the FDA.
- Review case information to ensure all criteria are met to create a case including verification that trade names are correctly translated into INN (International Non-proprietary Name).
- Triage (based on MedDRA coding and the company list of mandatory serious terms) and prioritization of cases based on seriousness of adverse events in accordance with SOPs (Standard Operating Procedures) and regulatory guidelines.
- Initialize or enter follow-up information into the Argus affiliate database, ensuring each case is unique, avoiding duplicate reporting to the FDA by performing accurate duplicate checks.
- Identify and follow department procedures for AEs associated with product complaints.
- Create action items for follow-up requests or other source documentation clarifications and issue follow-up correspondence to reporter (letter, e-mail, phone out, etc.).
- Manage Argus affiliate database worklists including, but not limited to, action items from central or local and not routed list.
- The Safety Data Associate must possess a notable level of vigilance to clearly identify cases that require high priority processing to effect prompt reporting of serious adverse events in support of the company's compliance with FDA, and global regulations.
- Under daily supervision, the incumbent researches and analyzes adverse event source documents received in Drug Safety for the accuracy of case reports insuring compliance with federal regulations by identifying problems, omissions or inconsistencies (eg patient identifiers such as age, race, sex, weight, height, conflicting histories, and inaccuracies).
- The incumbent must promptly and accurately enter case report information into the Argus affiliate database to initiate the case workflow and support adherence to company case processing and Regulatory Authority timelines.
- The incumbent will perform accurate and timely assessment of case seriousness which directly impacts on compliance reporting to both the FDA and global regulatory authorities as well as department compliance with internal timelines.

WHAT YOU NEED TO BRING TO THE TABLE:

- Global drug safety database knowledge and MedDRA is preferred along with knowledge of regulatory roles and proficiency with regulations, locally as well as globally.
- Knowledge of BCC PV processes, BCC SOPs and procedures, GPV global safety database, BCC rules regarding case processing and knowledge of GPV workflow processes.
- Must be detail oriented and be willing to work in a hectic paced environment with time-sensitive materials.
- Willing to provide back-up for other members with similar responsibilities based on relative workloads, to assure all team members with within reporting timelines.
- Quality traits of diplomacy, professionalism, tact, and arbitration are important.

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- BS degree in Life Science, Pharmacist, Registered Nurse, LPN or other HCP with at least 2 years of medical/surgical nursing or similar clinical setting; relevant experience in PV preferred.

RECRUITER: Mary Nguyen

Yoh, a DayJ2W: CLINICAL

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