Pharmacovigilance Manager (Remote)

JOB PURPOSE: Is responsible for directing and overseeing Pharmacovigilance activities and ensuring company compliance with all applicable legal and regulatory requirements and with clients agreements, for safety management of medicinal products in the countries were the company provides services.

This role is responsible for the quality and compliance of PV deliverables, training, audits/inspections, client relationship management and line management. This position is a senior role reporting to the General Manager.

KEY ACCOUNTABILITIES

To perform this job successfully an individual must be able to perform each essential function satisfactorily.

• Sets direction for pharmacovigilance activities for ensuring compliance with all applicable laws and regulations and as appropriate, local and foreign regulatory reporting requirements.for
• Establishes the Pharmacovigilance Area direction, standards, and processes for supporting company operations.
• Oversees and contributes to the daily operations of the Pharmacovigilance area
• Oversees the activities of vendors or independent professionals, contracted to perform pharmacovigilance activities.
• Oversees the activities for monitoring adverse event reports for potential drug-safety related issues and provides recommendations when potential issues are identified.
• Provides leadership and assists with collaborators
• Provides expert functional advice and assistance to other functions as needed.
• Facilitates and ensures communication with other areas.
• Collaborates with and provides pharmacovigilance guidance and support to client’s initiatives.
• Collaborates with partners to ensure proper exchange of drug-safety data.
• Aligns area activities in support of client’s goals, as appropriate.
• Acts as line manager of assigned staff. Collaborate in the recruitment of new staff in PV Department.
• Ensures annual leave and sick leave are approved and taken in accordance with company guidelines and local laws. Is involved in objective setting and annual appraisals of staff
• Continuously works with internal and external clients to ensure satisfaction.
• Collaborate with the PV Team and with Quality Head in always ensuring training compliance by PV staff. Constantly works with the PV teams towards identification of new training and development opportunities for the PV department.
• Monthly reports: Ensures monthly activities are tracked to evaluate workload and take actions if needed. Shared these reports with the General Manager, Backoffice head or Commercial area
• Identifies out-of-scope activities and liaise with PV Project Manager and other internal areas to initiate and process changes required.
• Provides clarification on PV invoicing issues.
• Ensures pharmacovigilance aspects of projects are managed in line with budgets and agreed timelines to achieve client satisfaction.
• Assists with or generates and reviews proposals and costings for pharmacovigilance business.
• Audits: Collaborate in representing PV department during for-cause/maintenance client audits or regulatory authority inspections. Represents, along with Operations PV Head, the PV department during pre-qualification client audits.
• Generates and reviews departmental SOPs and Working Procedures.
• Any other responsibilities or tasks as assigned by the Management team

REQUIRED EDUCATION AND SKILLS

• An experienced professional with a strong background in Pharmacovigilance (At least 4 years’ experience in PV in a CRO, pharmaceutical industry or PV service providers.).
• Professional qualification Medical Doctor / Pharmacist / Chemistry / Biochemistry / Biologist/ Nutritionist.
• Excellent communication and time management skills to manage multiple projects at any one time. Strong team member and understand the need for effective communication at all levels. Confident in presenting to colleagues and clients with high standards for the quality of material presented.
• Proficiency with standard desktop computing programs (e-mail, Word, Excel) and relational databases.
• Self-motivated, highly organized, detail-oriented and able to multi-task with delivering high quality work.
• Must be able to manage their own work, with ability to prioritize, plan and organize work assignments while working under strict timelines.
• Must be able to develop business solutions to complex problems.
• Can do attitude and ability to take on other tasks as assigned.
• Language skills: Fluent/Advanced: English. Native/Fluent: Spanish. knowledge of other languages would be an asset.
• Strong written and verbal communication skills
• Excellent understanding of business standards in the PV industry.
• Ability to: handle sensitive and confidential information; develop long and short-range plans to accomplish business goals and monitor performance against plans and objectives; use basic system applications; lead projects and teams and to travel, if needed; works effectively with colleagues and clients and facilitates achievement of common goals; challenge current state, suggest alternative approaches to improve work practices, and commit to defined changes.
• Knowledge of: drug development processes and activities; medical concepts, terms, Knowledge of MedDRA terminology and its application; Strong knowledge of local, regional and global PV requirements and legislation; Strong analytical thinking to diagnose common situations, gather and review relevant information, and recommend solutions
• the ability to lead a team to achieve set goals.
• Good communication
• Strong interpersonal and communication skills in cross-functional teams