Job objective:

• Process, document and scientifically evaluate relevant information on drug safety, drug risks and adverse events, and other relevant information;
• Coordination of essential pharmacovigilance actions to be undertaken, in accordance with legal requirements;
• Monitor, collect and document potential reports of drug-related risks by screening various reporting sources and databases;
• Coordinate, organize and manage the pharmacovigilance team.

Tasks and Responsibilities:

• Manages medication risk notification requirements for the Hospital Care Division of B. Braun Melsungen AG.
• Participation in the establishment and supervision of the pharmacovigilance system of BBMAG
• Coordinates the following activities:

• • Review of the scientific literature and relevant databases on suspected drug-related risk reports (suspected adverse reactions and special situations) and additional information relevant to the safety of the medicinal product;
  • Collection of spontaneous reports after the granting of the marketing authorization, based on the reported cases and on the evaluation of publications in the scientific literature;
  • Collection of additional information on the risks of medicinal products in the case of spontaneous referrals and referrals received by the company from the authorities;
  • Pharmaco-scientific evaluation of the potential for induction of adverse effects by drugs, other suspected adverse events and special situations;
  • Development of scripts for testing LSMV version updates, operationally or assigning this task to appropriately qualified personnel.

• Assesses the impact of the updates related to the LSMV launch from an operational point of view or assigning this task to appropriately qualified staff.
• Queries databases, compiles statistics, creates presentations and reports, such as compliance reports, monthly and annually.
• Works on issues where situational or data analysis requires a thorough understanding of organizational objectives. Implements strategic policies when selecting methods, techniques and evaluation criteria to achieve results.
• Reviews and updates all SOPs, SOPs and other relevant process documents related to ICSR processing or assigns this task to appropriately qualified personnel.
• Is the main point of contact for the Pharmacovigilance team in Romania in dealing with authorities, contracted consultants, affiliates and during audits.
• Ensures preparation of team deliverables in line with Global Pharmacovigilance & Patient Safety (GPVS) requirements.
• Functional and disciplinary management of the pharmacovigilance team in accordance with the principles stipulated in the company guidelines.
• Contributes to budget and staff planning.
• Establishes and ensures adherence to budgets, programs, work plans and performance requirements.
• Sets operational objectives and work plans and delegates tasks to subordinates.
• Evaluates and provides feedback on individual performance to team members.
• Prepares and conducts trainings specific to Pharmacovigilance processes for colleagues, dedicated staff and new hires.

• Performs ongoing and periodic advanced trainings to be up to date with terminology (e.g. MedDRA), pharmacovigilance expertise, and regulatory procedures and requirements in area of responsibility.
• Responsible for selection and hiring of new pharmacovigilance team members in conjunction with the Direct and Functional Manager as appropriate.
• Provide direction, instruction and guidance to the team.
• Plan and supervise/ monitor team activities quantitatively and qualitatively.
• Initiates sub-groups or sub-teams as needed to accomplish various tasks.
• Manages team work time.
• Prepares data for reports on team progress and status of ongoing projects.
• Engages in the development, modification and execution of company policies that affect immediate operations and may also have company-wide effect. Informs, interacts and coordinates with relevant departments and partners, e.g. affiliates and contract partners or supports those involved in the respective tasks.
• In addition to the defined tasks, the job holder is required to perform individual tasks, as instructed by his/her superior, which pertain to his/her work or are necessary for the functioning of the department or organization.
• Ensuring/ adhering to the compliance regulations of the "Employee Code of Conduct".

Professional competencies / Ideal candidate:

• Higher studies in pharmaceuticals or medicine; bachelor degree;
• Recommended: postgraduate studies (Master, PhD);
• Specialized courses;
• Minimum 3 years experience in the field;
• Recomended - 3 years leadership experience;
• Knowledge of English (advanced level);
• Knowledge of Microsoft Office;
• Has good writing and messaging skills for various audiences;
• Has knowledge of medicine and/or clinical pharmacology;
• Has leadership skills; is a committed, authentic leader with a high sense of accountability and a penchant for the essentials;
• Has experience in completing various information in databases;
• Easily correlates specialized information (e.g. how a drug works on the body and its effects);
• Has a strong desire to perform, is committed and assertive;
• Works successfully in complex structures and sets high quality standards;
• Is characterized by a goal-oriented, independent and structured working style;
• Very good communication, teamwork skills and flexibility;
• Intercultural skills.

• Acts with customer focus;
• Learns Actively;
• Delivers performance & results;
• Cooperates Constructively;
• Appreciates and include different perspectives.

Benefits:

• Unlimited period contract;
• Annual performance bonus;
• Work from home most of the time (80%) – Office work takes place in Sânandrei, Timis County;
• Meal tickets;
• Health subscription (free or discounted medical services);
• 7 Card subscription;
• A premium for family events, according to the Collective Labor Agreement;
• Partial settlement costs for the purchase of eyeglasses;
• Free coffee and dynamic work atmosphere.

 B. Braun Shared Services Romania | Adriana Nai |