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Manager DrugSafetSurveNMD


Khwaeng Lumphini, Krung Thep Maha Nakhon 10330
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Job Details

**Worldwide Safety and Regulatory (WSR)** **Job Description (JD)**

**Job Title:**

Country Safety Lead


Worldwide Safety (WWS)

**Line (if applicable)**

Safety Evaluation & Reporting (SER)

**Department/Group (if applicable)**

Global Pharmacovigilance Office (GPO)

**Region and/or Country (if applicable)**

As applicable

**Version Date:**


**Organizational Relationship(s) including to whom the position reports (JD Job Title):**

Reports to Head of GPO or Drug Safety Unit Regional Head (DRH) or Cluster Safety Lead

**Position Purpose**

Active contribution to the activities relevant to the pharmacovigilance system to ensure monitoring of the safety profile of Pfizer products and to meet regulatory requirements.

Contact point in the country, internally and externally, for safety-related aspects.

Manage resources in the country.

**Primary Responsibilities**

+ Efficient, high-quality execution of safety-related activities

+ Performance towards corporate functions and local compliance towards regulatory bodies

+ Efficient management of resources in the Drug Safety Unit (DSU). In detail:

Ensure fulfilling of drug safety-related obligations for the country

Where required by regulations, act as local contact or local QP PV

Participate in country activities as DSU point of contact for Pharmacovigilance Business Line

Ensure timely and accurate handling of individual and aggregate reports to meet corporate and regulatory reporting requirements for the country

Ensure timely handling of local safety issues; manage local safety issues in collaboration with central safety functions and local stakeholders

Support timely handling of local safety-related regulatory requests

Maintain expertise in country as well as worldwide regulations and guidelines and promote increased awareness of the legislative and regulatory environment in the country

Act as country's point contact for Safety, internally and externally

Represent Pfizer pharmacovigilance in local industry associations and other external groups

Support local, internal and external safety activities in collaboration with internal and external stakeholders

Monitor, and actively conduct as needed, local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency and any other required country-specific safety activity

Monitor and conduct as needed, local materiovigilance activities, including medical device incident monitoring and reporting as required by local agency, and any other required country-specific device safety activity

Organize and manage the country safety group to ensure effective coverage of safety-related activities

Develop and maintain knowledge of applicable SOPs, CP and other procedural documentation

Provide guidance to the country group for standardization of processes and goals

Manage and monitor the effective rollout of processes

Facilitate resolution of concerns and questions

Mentor colleagues on the effective use of the corporate safety database

Organize and manage inspection readiness activities in the country

Take responsibility for implementing corrective actions resulting from timeliness or quality issues associated with safety-related activities for the country

Support the standardization and quality of local safety data exchange agreements

Monitor and manage training of DSU, and ensure coaching and mentoring

Organize and manage recruitment for the DSU; fully utilize corporate tools, to manage the performance reviews of assigned colleagues in the country

Manage and monitor cost of the country team and relevant safety activities

**Technical Skill Requirements**

+ Knowledgeable in pharmaceutical business, including drug development and regulatory aspects

+ Good understanding of medical and scientific terminology

**Qualifications (i.e., preferred education, experience, attributes)**

+ Degree / Advanced degree in medicine or in life sciences or equivalent experience

+ Several years of experience in the pharmaceutical industry in pharmacovigilance or clinical research or product development

+ Rational approach to issues and their business implications

+ Good problem solving and decision making skills

+ Team building and team management experience

+ Strong interpersonal skills, with a demonstrated ability to manage people and foster teamwork

+ Excellent communication and negotiation skills - ability to manage discussions and decision making across cultures

+ Highly skilled in time management and change management, organizational and facilitation skills

+ Ability to meet personal objectives while meeting departmental standards of performance

+ Comfortable working in a matrix environment

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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