Company

KCR

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Senior Pharmacovigilance Specialist

Publication

2022-05-13

Company description

KCR is a clinical development solutions provider for the biotechnology and pharmaceutical industries. We support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR now operates across five regions: North America, Western Europe, Central Europe, Eastern Europe, and Australia, with a main operational hub located in Boston, MA. Our strategic hub locations, technical capabilities and solution offerings allow for the optimized delivery of trial execution strategies to develop life-changing therapies. KCR offers access to an estimated population of 1.1 Billion people. For more information visit www.kcrcro.com.

We see the human behind every number.

KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations. Founded in 1997, our expert teams support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across North America, Europe, and Australia, with main office locations in Boston US, Berlin Germany, and Warsaw Poland. Our geographical coverage across 25+ countries, cutting-edge technical capabilities and tailored offerings allow for the optimized delivery of solutions to develop life-changing therapies. KCR offers access to an estimated population of 1.1 billion people. For more information visit www.kcrcro.com.

We see the human behind every number.

 
Senior Pharmacovigilance Specialist  
Location: Poland (hybrid or home-based)

 

Senior Pharmacovigilance Specialist is responsible for realization of safety management/Pharmacovigilance (PV) activities mainly related with different aspects of adverse event information processing according to Standard Operating Procedures (SOP), project specific plans, ICH Good Clinical Practice (ICH GCP), Good Pharmacovigilance Practice (GVP) and all other applicable regulations and standards. 

 

Responsibilities:

  • Receives and processes adverse event (AE) reports and other information related with adverse events of medicinal products and medical devices according to applicable regulatory requirements, SOPs, Safety Management Plans and guidelines;
  • Performs review, analysis, triage and filing of AE information within established timeframes;
  • Processes AE information in relevant computerized system (e.g. PV database): data entry, encoding, case narrative writing, quality control, reconciliation;
  • Ensures quality, compliance and consistency of all steps of AE processing activities (case management);
  • Cooperates with Medical Monitor/Medical Reviewer and Investigators to collect all required information and determine AE medical assessment;
  • Coordinates workload arrangement activities to ensure timely and adequate distribution of workload for assigned team;
  • Receives, verifies and/or assists in preparation (writing, compilation) of expedited and periodic safety reports (including Suspected Unexpected Serious Adverse Reactions (SUSAR), DSUR, Line listings, IND safety reports);
  • Performs safety reports submissions to investigators, regulatory authorities (RA) (including EudraVigilance) and ethics committees (EC) within established timeframes and according to relevant regulatory requirements and SOPs;
  • Develops PV documentation including: SOPs, instructions, Safety Management Plans under PV Manager supervision;
  • Effectively communicates with internal and external stakeholders, participates in internal and external team meetings;

Requirements:

  • Bachelor's degree, Master's degree or certification in a life-science / healthcare / pharmaceutical related fields;
  • Experience in pharmacovigilance/safety area (preferably minimum 2 years);
  • Very good knowledge of ICH GCP and other ICH/EMA/FDA and local regulations and standards applicable for PV area;
  • Good knowledge of PV systems/databases (e.g. Oracle ARGUS);
  • Strong organizational, workload prioritization and time management skills;
  • Excellent communication and interpersonal skills;
  • Able to work well independently or within teams and effective in collaborating with others internally and externally;
  • Able to work under time pressure in a changing environment with flexibility;
  • Strong customer orientation/focus with strong sense of urgency;
  • Fluent verbal and written English language skills.

 

At KCR we put our mission: WE SEE HUMAN BEHIND EVERY NUMBER into our actions, therefore we offer our Employees benefits that comply with national regulations and provide the coverage that best meets employee needs.
To show that you are appreciated in our team, while working at KCR you will be provided with:

  • Ability to join fast-growing international CRO company and develop knowledge of clinical trials industry;
  • Possibility of getting involved in multinational studies;
  • Onboarding process to enable you fast takeover of duties;
  • Peer Buddy Mentor who will introduce you to the organization;
  • Open culture based on our values: learning, customer focus, accountability, commitment, tenacity and determination to succeed;
  • Empowering workspace, offering opportunities to share ideas and influence company services development worldwide;
  • Mentoring and training programs related with clinical trials, therapeutic areas, soft skills development;
  • Additional days-off for certain occasions.