Job Summary & Responsibilities
The Senior Director, Pharmacovigilance and Medical Safety creates and manages the infrastructure to support the medical component of pharmacovigilance. This involves providing scientific/clinical pharmacovigilance (PV) and Medical Safety drug safety (MS) expertise with a focus on the identification, evaluation and management of safety risks for all of IPM’s products throughout the product lifecycle. He/she also leads and contributes to the collection, processing, assessment, monitoring and follow-up of Adverse Event (AE) and Serious Adverse Event (SAE) reports from clinical trials in compliance with Good Clinical Practice (GCP), company Standard Operating Procedures (SOPs), and other applicable guidelines and regulations as appropriate.
The incumbent works cross-functionally with internal departments and external resources on PV/MS related issues and supports adherence to relevant regulatory requirements and company SOP’s as appropriate.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily
- Take responsibility on a strategic level for providing direction to the PV/MS team.
- Independently and with minimal supervision lead and manage the day to day activities of the PV/MS team.
- Provides PV/MS expertise in-house and by consultation with outside vendors for all development programs and market products; responsible for the oversight of Clinical Research Organizations (CROs) activities for both post marketing and clinical trials.
- Manages the development, implementation and on-going enhancement of safety surveillance processes and the associated SOPs and Safety and Medical Management Plans (SMMP); manages PV/MS reporting process and safety review and risk management activities.
- Participates in the identification, assessment and communication of potential safety signals
- Collaborates with Regulatory Affairs to ensure appropriate reporting of PV/MS information to regulatory agencies in a timely manner.
- Directs and provides key input for the review of new or ongoing safety documents that ensure compliance with local and international regulatory requirement that include, but may not be limited to, protocols, regulatory reports and Safety Data Exchange Agreements (SDEAs).
- Provides input for the preparation and/or review of safety summaries for Periodic Benefit-Risk Evaluation Report (PBRER), Investigator Brochures (IBs), Developmental Safety Update Reports (DSURs), and Annual Reports for submission to health authorities and other stakeholders; manages and contributes to the development of clinical study SAE reports, reviews for medical/regulatory content and assures accuracy per protocol requirements.
- Participates in investigator meetings to train investigators and qualified site personnel in the collection and reporting of SAEs; interfaces with medical monitors for medical assessments and the proper regulatory classification of SAEs; reconciles SAEs with the clinical study database during and after study completion; collects, processes and reports on all post-marketing SAEs.
- Represents the PV/MS function in development project teams and provides clinical guidance for pharmacovigilance activities through internal collaboration with Regulatory Affairs, Biostatistics, Clinical Operations, Global Quality Assurance (QA) and local Quality Management and Compliance and others, as necessary
- Any other responsibility as assigned.
Job Specifications
Candidates for this position should have the following education/experience and demonstrate mastery of the following knowledge, skills, and abilities
Education/Experience
- MD or equivalent scientific qualification and a minimum of 8 years of progressively responsible related experience (minimum 5 years in a PV/MS role) in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment.
- Expert knowledge of relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonisation (ICH) guidelines, initiatives, and regulations governing drug safety reporting and PV/DS in the conduct of clinical trials
- Extensive working knowledge of medical terminology and principles of clinical assessment of AEs/SAEs in the pharmaceutical/biotechnology industry.
- Familiarity with HIV/AIDS and/or Africa/Asia medical settings would be ideal, but is not required.
Knowledge, Skills and Abilities
- Strategic thinking ability and the ability to work independently with minimal guidance and supervision.
- Expertise in Medical Dictionary of Regulatory Activities (MedDRA) with relevance to AE/SAE coding.
- Demonstrated hands-on experience identifying, developing and implementing improvements to departmental processes that increase efficiency and maintain or improve quality (e.g., SAE reporting throughput rate).
- Demonstrated ability to identify opportunities to improve the PV/MS reporting processes.
- Ability to review and interpret lab test results for clinical significance.
- Expertise in the use of Electronic Document Management System (eDMS) software.
- Expertise in World Health Organization’s Drug Dictionary (WHODD) with relevance to coding suspect drug and concomitant medications.
- Ability to influence without direct authority.
- Proficiency with Microsoft Office.
- Excellent verbal and written communication and skills.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Terms and Conditions
This position is based in the Clinical Affairs department of the IPM office in Paarl, South Africa. However, home based applicants based in Europe will also be considered.
Domestic and/or international travel required. IPM is an Equal Opportunity Employer. This job description should not be construed to imply that these requirements are the only standards for the position. Other duties will be assigned. IPM has the right to revise this job description at any time.
More Information
- Job City Paarl
