Our Job Offers

THR-US1802 : Pharmacovigilance Associate in Data Management  – US – NJ

Teelia is a multinational consulting company founded in 2013 providing comprehensive & customized solutions to Pharmaceutical companies with their regulatory, clinical & Pharmacovigilance requirements, in the US, EMEA & APAC regions.

We are recruiting a Pharmacovigilance associate in Data Management to join our dedicated team of Pharmacovigilance experts in the US. The incumbent will work on our client’s premises.

The Pharmacovigilance associate in Data Management is responsible primarily for supporting Pharmacovigilance cases processing & aggregate reports preparation in compliance with enforced regulations, procedures, and contractual requirements.

Details

Responsibilities:

 

  • Perform ICSRs end-to-end processing in a timely & compliant fashion: case intake, registration & acknowledgement, data entry, MedDRA coding, peer-review & quality check, submission, archiving, reconciliations, follow-up with reporters.
  • Perform medical evaluation if the incumbent is either Pharm D or MD and experienced, and/or work closely with medical evaluators in charge.
  • Support PV quality system, which includes supporting the management of all PV SOPs (processes and working instructions), CAPAs, and inspection related activities, as well as a Quality & Compliance system for all PV documents.
  • Support the preparation of PV aggregate reports PSURs, DSURs (data retrieval).
  • Support the preparation of RMPs, and more specifically additional risk minimization tools, effectiveness evaluations.
  • Literature searches & screening for valid cases.
  • Assist in preparation & take part to PV commitments related to vendor audits, internal audits, regulatory inspections.
  • Contribute to the collection, organization, and presentation of all required global PV compliance metrics including vendor and partner oversight metrics.
  • Other duties as assigned or as business needs require.

 

Job Requirements

  • Degree in nursing, pharmacy, clinical pharmacy, medicine, veterinary medicine, health sciences
  • At least 1 year of relevant experience in Pharmacovigilance within pharmaceutical companies or Health Authorities settings

Competencies

  • Agility, polyvalence
  • Good communication skills, assertiveness
  • Fluent spoken & written English
  • Teamwork skills
  • Ability to work under pressure in a stressful but rewarding environment
  • Previous exposure to quality and compliance preferably related to Pharmacovigilance
  • Must be detail oriented, capability to meet deadlines
  • PC skills to include solid working knowledge of Microsoft Office software (Excel, Word & PowerPoint required)
  • Analytical capability

 

Seniority Level

Junior to mid-senior level

Employment Type

Full-time

Job Locations

Princeton, NJ

Bridgewater, NJ

Morristown, NJ

Home-based up to 2 days a week possible upon customer’s agreement

Disclaimer

Teelia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

THR-US1801 : Drug Safety Officer – US – NJ

Teelia is a multinational consulting company founded in 2013 providing comprehensive & customized solutions to Pharmaceutical companies with their regulatory, clinical & Pharmacovigilance requirements, in the US, EMEA & APAC regions.

We are recruiting a Senior Drug Safety Officer (DSO) to join our dedicated team of Pharmacovigilance experts in the US, NJ. The incumbent will work on our client’s premises.

Details

The senior DSO is responsible for supporting Pharmacovigilance operations  in compliance with enforced regulations, procedures, and contractual requirements.

Job Description:
  • Ensure oversight of ICSRs’ end-to-end processing in a timely & compliant fashion: case intake, registration & acknowledgement, data entry, MedDRA coding, medical evaluation, peer-review & quality check, submission, archiving, reconciliations, follow-up with reporters.
  • Support PV quality system, which includes supporting the management of all PV SOPs, CAPAs, and inspection related activities, as well as a Quality & Compliance system for all PV documents.
  • Third line medical information (including off-label use inquiries) in compliance with company SOPs & enforced regulations.
  • Support the writing & submission of PV aggregate reports PSURs, DSURs.
  • Support the writing and implementation of RMPs, and more specifically of additional risk minimization tools, effectiveness evaluations.
  • Answer to Health Authorities’ requests & lead ad-hoc response.
  • Monitor global Pharmacovigilance regulatory intelligence to determine impact on company Pharmacovigilance processes & quality system.
  • Assist in monitoring PV commitments from vendor audits, internal audits, regulatory inspection findings, and CAPAs.
  • Make contributions to the PV System Master File (PSMF) to ensure it is maintained on a permanent basis.
  • Contribute to the collection, organization, and presentation of all required global PV compliance metrics including vendor and partner oversight metrics.
  • Lead and support the development and implementation of the global PV training strategy (training matrix development, process, contribute to the collection, organization, and presentation of all required global PV compliance metrics including vendor and partner oversight metrics.
  • Assist in preparation and inspection activities during Regulatory Agency inspections and internal audits.
  • Remain up-to-date with global Pharmacovigilance regulations and requirements, evaluate legislative changes affecting PV, and develop strategies to support patient safety at the local level.

 

 

Job Requirements

  • Pharm D or MD
  • 3-5+ years of experience within pharmaceutical companies or Health Authorities settings in Pharmacovigilance

 

 

Competencies

  • Strong clinical expertise
  • Agility, polyvalence
  • Quality and compliance background preferably related to Pharmacovigilance
  • Demonstrated analytical and process skills and the ability to apply these skills to the customer’s PV organization
  • Effective communication, consulting, customer service and problem-solving skills
  • Must be detail oriented, capability to meet deadlines
  • PC skills to include solid working knowledge of Microsoft Office software (Excel, Word & PowerPoint required)
  • Excellent time and project management skills
  • Strong interpersonal skills and ability to interact with all levels of the organization and cross-culturally
  • Strategic planning exposure, open to innovation
  • Build positive relationships with regulators, inter and intradepartmental customers, internal and external stakeholders
  • Analyze and interpret regulations and laws and apply to current and future customer’s policies and procedures (may include collaboration with other cross functional areas)
  • Global mindset required
  • Demonstrated ability to speak up & influence others

 

Seniority Level

Mid-Senior level

 

Employment Type

Full-time

 

Job Locations

Princeton, NJ

Bridgewater, NJ

Morristown, NJ

Home-based 2 days a week possible upon customer’s agreement

 

Disclaimer

Teelia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.