Sr. Specialist / Associate Manager / Manager, Safety Evaluation & Risk Management

Position Summary
Manages drug safety medical rev******** signal evaluation an********management, an******** reports an******** to both internal an********parties following applicable regulat******** SOPs an******** guidelines.Provide operational support across all safety service lines asappropriate.

Key Responsibilities
Conduct Safety Medical Review
1. Perform single case medical assessment, including the determinationof ser******** expectedness / l******** an******** of adverse events incompliance with current regulat******** internal an******** guidance******** Standar******** Proce******** an******** processing / codingconventions.
2. Develop aggregate safety reports require******** regulatoryagenc******** when authorize******** perform this function on behalf ofa client.
3. Identify an******** safety signals base******** individual casesan******** data assessment. Communicate these findings proactivelyan******** to the key stakeholders.
4. Develop safety risk management strategy an******** through the******** assessment, commun******** an******** of risk for the productsper client or project needs.
5. Provide medical advice an******** to department colleagues to improvethe ******** cons******** accuracy, an******** relevance of safetyreports.
6. Develop an******** comprehensive an******** knowledge for theassigne******** an******** portfolio.
7. Develop an******** a comprehensive working knowledge of currentregulations governing the processing an******** of safety ********Standar******** Proce******** an******** processing / codingconventions.
8. Support medical an******** monitoring on clinical developmentprojects as needed.
9. Develop therapeutic area knowledge an******** medical review processexpertise.

Support Project Management an******** to Team Result
1. Support the achievement of the team case processing performancetimelines.
2. Liaise with clients an******** part******** e.g. project management,cl******** data management, ******** medical mon******** an********coordinators to address project issues an******** issue resolution.
3. Assist with administrative support e.g. project start-up tasks,creation an******** of project f******** systems access re********coordinating team/departmen******** oversight group meetings.
4. Collaborate cross Drug Safety & Pharmacovigilance sub-functionlines for seamless cooperation on projects an******** delivery.

Comply with Regulatory an******** Requirements
1. Ensure consistency an******** of the medical review process.
2. Ensure compliance to all necessary dMe******** operating procedures(SOPs) an******** SOPs, an******** require******** are execute******** atimely manner an********.
3. Take responsibility for audi******** readiness for pharmacovigilancemedical review activities; support audit an******** authorityinspections when needed.
4. Learn regulatory requirements an******** changes to apply to the workfor compliance.

Professional Experience an******** Requirements
1. Medical Degree from an accredite********.
2. Experience as a license******** in clinical practice is a plus.
3. Minimum of two years of relevant experience in pharmacovigilance orclinical research.
4. Working knowledge of international regulations an******** documentsgoverning safety evaluation an********. General knowledge about clinicaldevelopment process.

Key Competency Requirements
1. Knowledge of pharmacovigilance processes or in particularpharmacovigilance function line; willingness an******** to learn newskills across pharmacovigilance service lines.
2. Goo******** of applicable global, reg******** local clinical researchregulatory requirements; i.e. Goo******** Practice (GCP) an********Conference of Harmonization (ICH) gu******** Standar******** procedures(SOPs).
3. Excellent attention to detail an******** an******** consistenthigh-quality standards.
4. Ability to follow instructions / gu******** plan own work, workindependently with can-do attitude.
5. Ability to be flexible an******** to changing process demands.
6. Ability to establish an******** effective working relationships withcoworkers, managers an********.
7. Fluency in oral an******** Engl******** with sol******** in writingmedical an******** materials or content.